Chaetomium (Page 4 of 4)

HOW SUPPLIED

Stock concentrates are available in concentrations of 2-10% or weight/volume (w/v) of 1:50, 1:33, 1:20 or 1:10. Some juicy or liquid foods are available at 1:1 volume/volume (v/v) extraction ratio. Fresh egg white extract is available at 1:9 v/v extraction ratio.

Antigen E content of ragweed mixtures ranges from 46-166 U/ml for Ragweed Mixture (Short/Giant/Western/Southern Ragweed), 47-239 U/ml for Short/Giant/Western Ragweed Mixture, and 106-256 U/ml for Short/Giant Ragweed Mixture. Refer to container label for actual Antigen E content.

Extract (stock concentrate) is supplied in 10, 30 and 50 ml containers. Extracts in 5 ml dropper bottles are available for prick-puncture testing. To insure maximum potency for the entire dating period, all stock concentrates contain 50% glycerine v/v.

STORAGE

Store all stock concentrates and dilutions at 2-8° C. Keep at this temperature during office use. The expiration date of the allergenic extracts is listed on the container label. Dilutions of the allergenic extracts containing less than 50% glycerine are less stable. If loss of potency is suspected, potency can be checked using side by side skin testing with freshly prepared dilutions of equal concentration on individuals with known sensitivity to the allergen.

REFERENCES

1. Bousquet, Jean: “In vivo methods for study of allergy: Skin tests” Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I, Chap. 19, pp 419-436, 1988.

2. Long, W.F., Taylor, R.J., Wagner, C.J., et al.: Skin test suppression by antihistamines and the development of subsensitivity, J. Allergy Clin. Immunol., pp. 76-113, 1985.

3. Holgate, S.T., Robinson, C., Church, Mike: Mediators of Immediate Hypersensitivity, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. I and II, pp 135-163, 1988.

4. Wasserman, S., Marquart, D.: Anaphylaxis, Third Edition, Allergy Principles and Practice, C.V. Mosby Co., Vol. 1, Chap. 58, pp. 1365-1376, 1988.

5. Reid, Michael J., Lockey, Richard F., Turkeltaub M.D., Paul C., Platts-Mills, Thomas. “Survey of Fatalities from Skin Testing and Immunotherapy 1985-1989”, Journal of Allergy and Clinical Immunology, Vol. 92, No. 1, pp. 6-15, 1993.

6. Matthews, K., et al: Rhinitis, Asthma and Other Allergic Diseases. NIAID Task Force Report, U.S. Dept. HEW, NIH Publication No. 79-387, Chapter 4, pp. 213-217, May 1979.

7. Ishizaka, K.: Control of IgE Synthesis, Third Edition, Allergy Principles and Practices, Vol. I, Chap. 4, p. 52, edited by Middleton et al.

8. Nelson, H.S.: “The Effect of Preservatives and Dilution on the Deterioration of Russian Thistle (Salsola pestifer), a pollen extract.” The Journal of Allergy and Clinical Immunology, Vol. 63, No. 6, pp. 417-425, June 1979.

9. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp. 84-86.

10. Rocklin, R.E., Sheffer, A.L., Grainader, D.K. and Melmon, K.: “Generation of antigen-specific suppressor cells during allergy desensitization”, New England Journal of Medicine, 302, May 29, 1980, pp. 1213-1219.

11. Seebohm, P.M., et al: Panel on Review of Allergenic Extracts, Final Report, Food and Drug Administration, March 13, 1981, pp 9-48.

12. Stevens, E.: Cutaneous Tests, Regulatory Control and Standardization of Allergenic Extracts, First International Paul-Ehrlich Seminar, May 20-22, 1979, Frankfurt, Germany, pp. 133-138.

13. Van Metre, T., Adkinson, N., Amodio, F., Lichtenstein, L., Mardinay, M., Norman, P., Rosenberg, G., Sobotka, A., Valentine, M.: “A Comparative Study of the Effectiveness of the Rinkel Method and the Current Standard Method of Immunology for Ragweed Pollen Hay Fever,“ The Journal of Clinical Allergy and Immunology, Vol. 66, No. 6, p. 511, December 1980.

14. Wasserman, S.: The Mast Cell and the Inflammatory Response. The Mast Cell-its role in Health and disease. Edited by J. Pepys & A.M. Edwards, Proceedings of an International Symposium, Davos, Switzerland, Pitman Medical Publishing Co., 1979, pp. 9-20.

15. Perelmutter, L.: IgE Regulation During Immunotherapy of Allergic Diseases. Annals of Allergy, Vol. 57, August 1986.

16. Bullock, J., Frick, O.: Mite Sensitivity in House Dust Allergic Children, Am. J. Dis. Child., pp. 123-222, 1972.

17. Willoughby, J.W.: Inhalant Allergy Immunotherapy with Standardized and Nonstandardized Allergenic Extracts, American Academy of Otolaryngology-Head and Neck Surgery: Instructional Courses, Vol. 1, Chapter 15, C.V. Mosby Co., St. Louis, Missouri, September 1988.

CONTAINER LABELING

5 mL Green Label
(click image for full-size original)
10 mL Green Label
(click image for full-size original)
30/50 mL Green Label
(click image for full-size original)
CHAETOMIUM chaetomium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0094
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (CHAETOMIUM GLOBOSUM) CHAETOMIUM GLOBOSUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0094-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0094-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0094-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0094-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0094-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CEPHALOSPORIUM cephalosporium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0089
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACREMONIUM STRICTUM (ACREMONIUM STRICTUM) ACREMONIUM STRICTUM 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0089-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0089-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0089-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0089-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0089-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CLADOSPORIUM HERBARUM cladosporium herbarum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0159
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM HERBARUM (CLADOSPORIUM HERBARUM) CLADOSPORIUM HERBARUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0159-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0159-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0159-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0159-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0159-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CURVULARIA curvularia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0098
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SPICIFER (COCHLIOBOLUS SPICIFER) COCHLIOBOLUS SPICIFER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0098-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0098-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0098-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0098-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0098-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BOTRYTIS botrytis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0039
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (BOTRYTIS CINEREA) BOTRYTIS CINEREA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
SODIUM CHLORIDE 0.0095 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0039-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0039-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0039-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0039-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0039-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ASPERGILLUS NIGER aspergillus niger injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0033
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0033-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0033-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0033-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0033-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0033-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/23/1974
CEPHALOSPORIUM cephalosporium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0088
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACREMONIUM STRICTUM (ACREMONIUM STRICTUM) ACREMONIUM STRICTUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0088-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0088-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0088-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0088-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0088-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BERMUDA GRASS SMUT bermuda grass smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0065
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO CYNODONTIS (USTILAGO CYNODONTIS) USTILAGO CYNODONTIS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0065-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0065-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0065-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0065-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0065-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HELMINTHOSPORIUM helminthosporium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0249
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0249-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0249-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0249-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0249-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0249-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HELMINTHOSPORIUM helminthosporium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0248
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0248-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0248-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0248-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0248-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0248-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
JOHNSON GRASS SMUT johnson grass smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0280
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPORISORIUM CRUENTUM (SPORISORIUM CRUENTUM) SPORISORIUM CRUENTUM 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0280-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0280-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0280-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0280-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0280-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
JOHNSON GRASS SMUT johnson grass smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0279
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPORISORIUM CRUENTUM (SPORISORIUM CRUENTUM) SPORISORIUM CRUENTUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0279-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0279-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0279-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0279-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0279-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
FUSARIUM OXYSPORUM fusarium oxysporum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0198
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0198-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0198-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0198-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0198-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0198-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
EPICOCCUM epicoccum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0187
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (EPICOCCUM NIGRUM) EPICOCCUM NIGRUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0187-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0187-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0187-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0187-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0187-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HORMODENDRUM hormodendrum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0246
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
SODIUM CHLORIDE 0.0095 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0246-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0246-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0246-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0246-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0246-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HORMODENDRUM hormodendrum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0245
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
SODIUM CHLORIDE 0.0095 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0245-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0245-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0245-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0245-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0245-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NUMBER FOUR MOLD MIXTURE number four mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0210
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 0.0125 g in 1 mL
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.0031 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.0031 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.0031 g in 1 mL
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.0031 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.0125 g in 1 mL
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.0021 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0021 g in 1 mL
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.0021 g in 1 mL
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.0021 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0021 g in 1 mL
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.0021 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0210-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0210-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0210-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0210-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0210-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GRASS SMUT MIXTURE grass smut mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0214
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO CYNODONTIS (USTILAGO CYNODONTIS) USTILAGO CYNODONTIS 0.05 g in 1 mL
SPORISORIUM CRUENTUM (SPORISORIUM CRUENTUM) SPORISORIUM CRUENTUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0214-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0214-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0214-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0214-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0214-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
GRAIN SMUT MIXTURE grain smut mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0211
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO NUDA HORDEI (USTILAGO NUDA HORDEI) USTILAGO NUDA HORDEI 0.025 g in 1 mL
USTILAGO MAYDIS (USTILAGO MAYDIS) USTILAGO MAYDIS 0.025 g in 1 mL
USTILAGO AVENAE (USTILAGO AVENAE) USTILAGO AVENAE 0.025 g in 1 mL
USTILAGO TRITICI (USTILAGO TRITICI) USTILAGO TRITICI 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0211-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0211-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0211-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0211-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0211-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
A MOLD MIXTURE a mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0004
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.0017 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.0017 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.0017 g in 1 mL
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.0017 g in 1 mL
BOTRYTIS CINEREA (BOTRYTIS CINEREA) BOTRYTIS CINEREA 0.0067 g in 1 mL
CHAETOMIUM GLOBOSUM (CHAETOMIUM GLOBOSUM) CHAETOMIUM GLOBOSUM 0.0067 g in 1 mL
EPICOCCUM NIGRUM (EPICOCCUM NIGRUM) EPICOCCUM NIGRUM 0.0067 g in 1 mL
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.0067 g in 1 mL
GEOTRICHUM CANDIDUM (GEOTRICHUM CANDIDUM) GEOTRICHUM CANDIDUM 0.0067 g in 1 mL
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.0067 g in 1 mL
CANDIDA TROPICALIS (CANDIDA TROPICALIS) CANDIDA TROPICALIS 0.0033 g in 1 mL
NEUROSPORA INTERMEDIA (NEUROSPORA INTERMEDIA) NEUROSPORA INTERMEDIA 0.0033 g in 1 mL
MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 0.0022 g in 1 mL
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.0022 g in 1 mL
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.0011 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0011 g in 1 mL
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.0011 g in 1 mL
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.0011 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0011 g in 1 mL
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.0011 g in 1 mL
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.0067 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.0067 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.0067 g in 1 mL
RHODOTORULA RUBRA (RHODOTORULA RUBRA) RHODOTORULA RUBRA 0.0067 g in 1 mL
SACCHAROMYCES CEREVISIAE (SACCHAROMYCES CEREVISIAE) SACCHAROMYCES CEREVISIAE 0.0067 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.0022 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0004-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0004-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0004-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0004-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0004-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
MICROSPORUM CANIS microsporum canis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0299
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICROSPORUM CANIS (MICROSPORUM CANIS) MICROSPORUM CANIS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0299-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0299-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0299-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0299-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0299-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
B MOLD MIXTURE b mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0035
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOTHECIUM ROSEUM (TRICHOTHECIUM ROSEUM) TRICHOTHECIUM ROSEUM 0.0071 g in 1 mL
PASSALORA FULVA (PASSALORA FULVA) PASSALORA FULVA 0.0071 g in 1 mL
COCHLIOBOLUS SPICIFER (COCHLIOBOLUS SPICIFER) COCHLIOBOLUS SPICIFER 0.0071 g in 1 mL
MYROTHECIUM VERRUCARIA (MYROTHECIUM VERRUCARIA) MYROTHECIUM VERRUCARIA 0.0071 g in 1 mL
HYPOMYCES PERNICIOSUS (HYPOMYCES PERNICIOSUS) HYPOMYCES PERNICIOSUS 0.0071 g in 1 mL
NEUROSPORA CRASSA (NEUROSPORA CRASSA) NEUROSPORA CRASSA 0.0071 g in 1 mL
KHUSKIA ORYZAE (KHUSKIA ORYZAE) KHUSKIA ORYZAE 0.0071 g in 1 mL
PAECILOMYCES VARIOTII (PAECILOMYCES VARIOTII) PAECILOMYCES VARIOTII 0.0071 g in 1 mL
MICROASCUS BREVICAULIS (MICROASCUS BREVICAULIS) MICROASCUS BREVICAULIS 0.0071 g in 1 mL
COLLETOTRICHUM COCCODES (COLLETOTRICHUM COCCODES) COLLETOTRICHUM COCCODES 0.0071 g in 1 mL
PLEOSPORA HERBARUM (PLEOSPORA HERBARUM) PLEOSPORA HERBARUM 0.0071 g in 1 mL
STREPTOMYCES GRISEUS (STREPTOMYCES GRISEUS) STREPTOMYCES GRISEUS 0.0071 g in 1 mL
TRICHODERMA VIRIDE (TRICHODERMA VIRIDE) TRICHODERMA VIRIDE 0.0071 g in 1 mL
TRICHOPHYTON SCHOENLEINII (TRICHOPHYTON SCHOENLEINII) TRICHOPHYTON SCHOENLEINII 0.0071 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 g in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0035-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0035-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0035-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0035-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0035-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
ASPERGILLUS MIXTURE aspergillus mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0007
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.0025 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.0025 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.0025 g in 1 mL
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.0025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0007-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0007-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0007-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0007-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0007-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ALTERNARIA ALTERNATA alternaria alternata injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0002
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0002-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0002-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0002-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0002-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0002-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NUMBER TEN MOLD MIXTURE number ten mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0586
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 0.01 g in 1 mL
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.0025 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.0025 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.0025 g in 1 mL
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.0025 g in 1 mL
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.01 g in 1 mL
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.01 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.01 g in 1 mL
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.01 g in 1 mL
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.0017 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0017 g in 1 mL
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.0017 g in 1 mL
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.0017 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0017 g in 1 mL
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.0017 g in 1 mL
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.01 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.01 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0586-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0586-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0586-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0586-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0586-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0031
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0031-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0031-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0031-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0031-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0031-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ALTERNARIA ALTERNATA alternaria alternata injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0003
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0003-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0003-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0003-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0003-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0003-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUCOR MIXTURE mucor mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0294
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 0.0333 g in 1 mL
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.0333 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.0333 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
SODIUM CHLORIDE 0.0095 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0294-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0294-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0294-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0294-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0294-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
MONILIA MIXTURE monilia mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0293
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA TROPICALIS (CANDIDA TROPICALIS) CANDIDA TROPICALIS 0.025 g in 1 mL
NEUROSPORA INTERMEDIA (NEUROSPORA INTERMEDIA) NEUROSPORA INTERMEDIA 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0293-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0293-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0293-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0293-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0293-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHOPHYTON MIXTURE trichophyton mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0576
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (TRICHOPHYTON MENTAGROPHYTES) TRICHOPHYTON MENTAGROPHYTES 0.05 g in 1 mL
TRICHOPHYTON RUBRUM (TRICHOPHYTON RUBRUM) TRICHOPHYTON RUBRUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0576-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0576-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0576-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0576-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0576-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
PENICILLIUM MIXTURE penicillium mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0363
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.0167 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0167 g in 1 mL
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.0167 g in 1 mL
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.0167 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0167 g in 1 mL
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.0167 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0363-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0363-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0363-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0363-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0363-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
GRAIN SMUT MIXTURE grain smut mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0213
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO NUDA HORDEI (USTILAGO NUDA HORDEI) USTILAGO NUDA HORDEI 0.005 g in 1 mL
USTILAGO MAYDIS (USTILAGO MAYDIS) USTILAGO MAYDIS 0.005 g in 1 mL
USTILAGO AVENAE (USTILAGO AVENAE) USTILAGO AVENAE 0.005 g in 1 mL
USTILAGO TRITICI (USTILAGO TRITICI) USTILAGO TRITICI 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0213-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0213-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0213-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0213-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0213-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 09/09/1997
GRAIN SMUT MIXTURE grain smut mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0212
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO NUDA HORDEI (USTILAGO NUDA HORDEI) USTILAGO NUDA HORDEI 0.0125 g in 1 mL
USTILAGO MAYDIS (USTILAGO MAYDIS) USTILAGO MAYDIS 0.0125 g in 1 mL
USTILAGO AVENAE (USTILAGO AVENAE) USTILAGO AVENAE 0.0125 g in 1 mL
USTILAGO TRITICI (USTILAGO TRITICI) USTILAGO TRITICI 0.0125 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0212-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0212-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0212-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0212-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0212-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 09/09/1997
GRASS SMUT MIXTURE grass smut mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0216
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO CYNODONTIS (USTILAGO CYNODONTIS) USTILAGO CYNODONTIS 0.01 g in 1 mL
SPORISORIUM CRUENTUM (SPORISORIUM CRUENTUM) SPORISORIUM CRUENTUM 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0216-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0216-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0216-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0216-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0216-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
GRASS SMUT MIXTURE grass smut mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0215
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO CYNODONTIS (USTILAGO CYNODONTIS) USTILAGO CYNODONTIS 0.025 g in 1 mL
SPORISORIUM CRUENTUM (SPORISORIUM CRUENTUM) SPORISORIUM CRUENTUM 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0215-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0215-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0215-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0215-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0215-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
B MOLD MIXTURE b mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0037
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOTHECIUM ROSEUM (TRICHOTHECIUM ROSEUM) TRICHOTHECIUM ROSEUM 0.0018 g in 1 mL
PASSALORA FULVA (PASSALORA FULVA) PASSALORA FULVA 0.0018 g in 1 mL
COCHLIOBOLUS SPICIFER (COCHLIOBOLUS SPICIFER) COCHLIOBOLUS SPICIFER 0.0018 g in 1 mL
MYROTHECIUM VERRUCARIA (MYROTHECIUM VERRUCARIA) MYROTHECIUM VERRUCARIA 0.0018 g in 1 mL
HYPOMYCES PERNICIOSUS (HYPOMYCES PERNICIOSUS) HYPOMYCES PERNICIOSUS 0.0018 g in 1 mL
NEUROSPORA CRASSA (NEUROSPORA CRASSA) NEUROSPORA CRASSA 0.0018 g in 1 mL
KHUSKIA ORYZAE (KHUSKIA ORYZAE) KHUSKIA ORYZAE 0.0018 g in 1 mL
PAECILOMYCES VARIOTII (PAECILOMYCES VARIOTII) PAECILOMYCES VARIOTII 0.0036 g in 1 mL
MICROASCUS BREVICAULIS (MICROASCUS BREVICAULIS) MICROASCUS BREVICAULIS 0.0018 g in 1 mL
COLLETOTRICHUM COCCODES (COLLETOTRICHUM COCCODES) COLLETOTRICHUM COCCODES 0.0018 g in 1 mL
PLEOSPORA HERBARUM (PLEOSPORA HERBARUM) PLEOSPORA HERBARUM 0.0018 g in 1 mL
STREPTOMYCES GRISEUS (STREPTOMYCES GRISEUS) STREPTOMYCES GRISEUS 0.0018 g in 1 mL
TRICHODERMA VIRIDE (TRICHODERMA VIRIDE) TRICHODERMA VIRIDE 0.0018 g in 1 mL
TRICHOPHYTON SCHOENLEINII (TRICHOPHYTON SCHOENLEINII) TRICHOPHYTON SCHOENLEINII 0.0018 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 g in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0037-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0037-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0037-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0037-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0037-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
B MOLD MIXTURE b mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0036
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOTHECIUM ROSEUM (TRICHOTHECIUM ROSEUM) TRICHOTHECIUM ROSEUM 0.0036 g in 1 mL
PASSALORA FULVA (PASSALORA FULVA) PASSALORA FULVA 0.0036 g in 1 mL
COCHLIOBOLUS SPICIFER (COCHLIOBOLUS SPICIFER) COCHLIOBOLUS SPICIFER 0.0036 g in 1 mL
MYROTHECIUM VERRUCARIA (MYROTHECIUM VERRUCARIA) MYROTHECIUM VERRUCARIA 0.0036 g in 1 mL
HYPOMYCES PERNICIOSUS (HYPOMYCES PERNICIOSUS) HYPOMYCES PERNICIOSUS 0.0036 g in 1 mL
NEUROSPORA CRASSA (NEUROSPORA CRASSA) NEUROSPORA CRASSA 0.0036 g in 1 mL
KHUSKIA ORYZAE (KHUSKIA ORYZAE) KHUSKIA ORYZAE 0.0036 g in 1 mL
PAECILOMYCES VARIOTII (PAECILOMYCES VARIOTII) PAECILOMYCES VARIOTII 0.0036 g in 1 mL
MICROASCUS BREVICAULIS (MICROASCUS BREVICAULIS) MICROASCUS BREVICAULIS 0.0036 g in 1 mL
COLLETOTRICHUM COCCODES (COLLETOTRICHUM COCCODES) COLLETOTRICHUM COCCODES 0.0036 g in 1 mL
PLEOSPORA HERBARUM (PLEOSPORA HERBARUM) PLEOSPORA HERBARUM 0.0036 g in 1 mL
STREPTOMYCES GRISEUS (STREPTOMYCES GRISEUS) STREPTOMYCES GRISEUS 0.0036 g in 1 mL
TRICHODERMA VIRIDE (TRICHODERMA VIRIDE) TRICHODERMA VIRIDE 0.0036 g in 1 mL
TRICHOPHYTON SCHOENLEINII (TRICHOPHYTON SCHOENLEINII) TRICHOPHYTON SCHOENLEINII 0.0036 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 g in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0036-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0036-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0036-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0036-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0036-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
A MOLD MIXTURE a mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0005
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.0008 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.0008 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.0008 g in 1 mL
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.0008 g in 1 mL
BOTRYTIS CINEREA (BOTRYTIS CINEREA) BOTRYTIS CINEREA 0.0033 g in 1 mL
CHAETOMIUM GLOBOSUM (CHAETOMIUM GLOBOSUM) CHAETOMIUM GLOBOSUM 0.0033 g in 1 mL
EPICOCCUM NIGRUM (EPICOCCUM NIGRUM) EPICOCCUM NIGRUM 0.0033 g in 1 mL
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.0033 g in 1 mL
GEOTRICHUM CANDIDUM (GEOTRICHUM CANDIDUM) GEOTRICHUM CANDIDUM 0.0033 g in 1 mL
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.0033 g in 1 mL
CANDIDA TROPICALIS (CANDIDA TROPICALIS) CANDIDA TROPICALIS 0.0017 g in 1 mL
NEUROSPORA INTERMEDIA (NEUROSPORA INTERMEDIA) NEUROSPORA INTERMEDIA 0.0017 g in 1 mL
MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 0.0011 g in 1 mL
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.0011 g in 1 mL
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.0006 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0006 g in 1 mL
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.0006 g in 1 mL
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.0006 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0006 g in 1 mL
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.0006 g in 1 mL
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.0033 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.0033 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.0033 g in 1 mL
RHODOTORULA RUBRA (RHODOTORULA RUBRA) RHODOTORULA RUBRA 0.0033 g in 1 mL
SACCHAROMYCES CEREVISIAE (SACCHAROMYCES CEREVISIAE) SACCHAROMYCES CEREVISIAE 0.0033 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.0011 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0005-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0005-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0005-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0005-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0005-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PENICILLIUM NOTATUM penicillium notatum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0417
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0417-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0417-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0417-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0417-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0417-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUCOR MIXTURE mucor mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0295
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 0.0167 g in 1 mL
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.0167 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.0167 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
SODIUM CHLORIDE 0.0095 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0295-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0295-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0295-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0295-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0295-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
A MOLD MIXTURE a mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0006
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.0004 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.0004 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.0004 g in 1 mL
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.0004 g in 1 mL
BOTRYTIS CINEREA (BOTRYTIS CINEREA) BOTRYTIS CINEREA 0.0017 g in 1 mL
CHAETOMIUM GLOBOSUM (CHAETOMIUM GLOBOSUM) CHAETOMIUM GLOBOSUM 0.0017 g in 1 mL
EPICOCCUM NIGRUM (EPICOCCUM NIGRUM) EPICOCCUM NIGRUM 0.0017 g in 1 mL
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.0017 g in 1 mL
GEOTRICHUM CANDIDUM (GEOTRICHUM CANDIDUM) GEOTRICHUM CANDIDUM 0.0017 g in 1 mL
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.0017 g in 1 mL
CANDIDA TROPICALIS (CANDIDA TROPICALIS) CANDIDA TROPICALIS 0.0008 g in 1 mL
NEUROSPORA INTERMEDIA (NEUROSPORA INTERMEDIA) NEUROSPORA INTERMEDIA 0.0008 g in 1 mL
MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 0.0006 g in 1 mL
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.0006 g in 1 mL
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.0003 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0003 g in 1 mL
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.0003 g in 1 mL
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.0003 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0003 g in 1 mL
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.0003 g in 1 mL
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.0017 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.0017 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.0017 g in 1 mL
RHODOTORULA RUBRA (RHODOTORULA RUBRA) RHODOTORULA RUBRA 0.0017 g in 1 mL
SACCHAROMYCES CEREVISIAE (SACCHAROMYCES CEREVISIAE) SACCHAROMYCES CEREVISIAE 0.0017 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.0006 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0006-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0006-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0006-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0006-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0006-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHOPHYTON MIXTURE trichophyton mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0577
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (TRICHOPHYTON MENTAGROPHYTES) TRICHOPHYTON MENTAGROPHYTES 0.025 g in 1 mL
TRICHOPHYTON RUBRUM (TRICHOPHYTON RUBRUM) TRICHOPHYTON RUBRUM 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0577-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0577-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0577-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0577-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0577-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PENICILLIUM MIXTURE penicillium mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0364
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.0083 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0083 g in 1 mL
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.0083 g in 1 mL
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.0083 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0083 g in 1 mL
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.0083 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0364-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0364-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0364-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0364-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0364-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NUMBER TEN MOLD MIXTURE number ten mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0587
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 0.005 g in 1 mL
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.0013 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.0013 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.0013 g in 1 mL
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.0013 g in 1 mL
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.005 g in 1 mL
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.005 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.005 g in 1 mL
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.005 g in 1 mL
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.0008 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0008 g in 1 mL
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.0008 g in 1 mL
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.0008 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.0008 g in 1 mL
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.0008 g in 1 mL
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.005 g in 1 mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.005 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0587-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0587-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0587-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0587-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0587-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHOPHYTON MIXTURE trichophyton mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0578
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (TRICHOPHYTON MENTAGROPHYTES) TRICHOPHYTON MENTAGROPHYTES 0.01 g in 1 mL
TRICHOPHYTON RUBRUM (TRICHOPHYTON RUBRUM) TRICHOPHYTON RUBRUM 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0578-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0578-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0578-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0578-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0578-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PHOMA phoma injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0366
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0366-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0366-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0366-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0366-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0366-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NIGROSPORA nigrospora injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0328
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KHUSKIA ORYZAE (KHUSKIA ORYZAE) KHUSKIA ORYZAE 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0328-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0328-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0328-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0328-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0328-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PULLULARIA pullularia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0369
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.025 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0369-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0369-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0369-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0369-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0369-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PULLULARIA pullularia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0368
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0368-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0368-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0368-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0368-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0368-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CANDIDA ALBICANS candida albicans injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0313
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (CANDIDA ALBICANS) CANDIDA ALBICANS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0313-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0313-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0313-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0313-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0313-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MYCOGONE PERNICIOSA mycogone perniciosa injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0297
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYPOMYCES PERNICIOSUS (HYPOMYCES PERNICIOSUS) HYPOMYCES PERNICIOSUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0297-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0297-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0297-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0297-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0297-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUCOR RACEMOSUS mucor racemosus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0319
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0319-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0319-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0319-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0319-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0319-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CANDIDA ALBICANS candida albicans injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0314
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (CANDIDA ALBICANS) CANDIDA ALBICANS 0.02 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0314-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0314-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0314-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0314-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0314-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHODERMA trichoderma injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0563
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHODERMA VIRIDE (TRICHODERMA VIRIDE) TRICHODERMA VIRIDE 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0563-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0563-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0563-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0563-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0563-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STACHYBOTRYS stachybotrys injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0471
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STACHYBOTRYS CHARTARUM (STACHYBOTRYS CHARTARUM) STACHYBOTRYS CHARTARUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0471-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0471-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0471-3 5 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0471-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0471-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ASPERGILLUS MIXTURE aspergillus mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0008
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.0125 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.0125 g in 1 mL
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.0125 g in 1 mL
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.0125 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0008-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0008-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0008-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0008-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0008-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHOPHYTON RUBRUM trichophyton rubrum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0580
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON RUBRUM (TRICHOPHYTON RUBRUM) TRICHOPHYTON RUBRUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0580-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0580-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0580-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0580-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0580-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RHIZOPUS rhizopus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0435
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0435-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0435-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0435-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0435-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0435-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PAECILOMYCES paecilomyces injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0371
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAECILOMYCES VARIOTII (PAECILOMYCES VARIOTII) PAECILOMYCES VARIOTII 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0025 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0371-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0371-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0371-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0371-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0371-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STEMPHYLIUM stemphylium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0467
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLEOSPORA HERBARUM (PLEOSPORA HERBARUM) PLEOSPORA HERBARUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0467-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0467-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0467-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0467-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0467-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SPONDYLOCLADIUM spondylocladium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0465
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLLETOTRICHUM COCCODES (COLLETOTRICHUM COCCODES) COLLETOTRICHUM COCCODES 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0465-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0465-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0465-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0465-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0465-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
WHEAT SMUT wheat smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0607
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO TRITICI (USTILAGO TRITICI) USTILAGO TRITICI 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0607-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0607-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0607-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0607-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0607-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 09/09/1997
GLIOCLADIUM gliocladium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0217
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYROTHECIUM VERRUCARIA (MYROTHECIUM VERRUCARIA) MYROTHECIUM VERRUCARIA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0217-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0217-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0217-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0217-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0217-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
FUSARIUM OXYSPORUM fusarium oxysporum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0197
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0197-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0197-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0197-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0197-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0197-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HORMODENDRUM hormodendrum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0244
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
SODIUM CHLORIDE 0.0095 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0244-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0244-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0244-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0244-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0244-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
GEOTRICHUM CANDIDUM geotrichum candidum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0228
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEOTRICHUM CANDIDUM (GEOTRICHUM CANDIDUM) GEOTRICHUM CANDIDUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0228-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0228-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0228-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0228-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0228-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CLADOSPORIUM HERBARUM cladosporium herbarum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0158
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLADOSPORIUM HERBARUM (CLADOSPORIUM HERBARUM) CLADOSPORIUM HERBARUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0158-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0158-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0158-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0158-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0158-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
CORN SMUT corn smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0143
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO MAYDIS (USTILAGO MAYDIS) USTILAGO MAYDIS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0143-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0143-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0143-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0143-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0143-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 09/09/1977
EPIDERMOPHYTON epidermophyton injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0194
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPIDERMOPHYTON FLOCCOSUM (EPIDERMOPHYTON FLOCCOSUM) EPIDERMOPHYTON FLOCCOSUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0194-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0194-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0194-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0194-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0194-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
EPICOCCUM epicoccum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0186
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPICOCCUM NIGRUM (EPICOCCUM NIGRUM) EPICOCCUM NIGRUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0186-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0186-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0186-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0186-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0186-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
CANDIDA ALBICANS candida albicans injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0312
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (CANDIDA ALBICANS) CANDIDA ALBICANS 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0312-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0312-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0312-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0312-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0312-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
CANDIDA TROPICALIS candida tropicalis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0320
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA TROPICALIS (CANDIDA TROPICALIS) CANDIDA TROPICALIS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0320-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0320-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0320-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0320-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0320-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUCOR RACEMOSUS mucor racemosus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0318
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR RACEMOSUS (MUCOR RACEMOSUS) MUCOR RACEMOSUS 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0318-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0318-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0318-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0318-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0318-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
JOHNSON GRASS SMUT johnson grass smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0278
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPORISORIUM CRUENTUM (SPORISORIUM CRUENTUM) SPORISORIUM CRUENTUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0278-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0278-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0278-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0278-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0278-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
HELMINTHOSPORIUM helminthosporium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0247
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0247-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0247-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0247-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0247-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0247-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
MICROSPORUM AUDOUINII microsporum audouinii injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0298
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICROSPORUM AUDOUINII (MICROSPORUM AUDOUINII) MICROSPORUM AUDOUINII 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0298-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0298-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0298-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0298-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0298-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MYCOGONE PERNICIOSA mycogone perniciosa injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0296
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYPOMYCES PERNICIOSUS (HYPOMYCES PERNICIOSUS) HYPOMYCES PERNICIOSUS 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0296-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0296-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0296-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0296-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0296-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0030
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0030-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0030-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0030-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0030-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0030-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
ASPERGILLUS REPENS aspergillus repens injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0621
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS REPENS (ASPERGILLUS REPENS) ASPERGILLUS REPENS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0621-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0621-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0621-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0621-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0621-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ASPERGILLUS NIGER aspergillus niger injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0032
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS NIGER VAR. NIGER (ASPERGILLUS NIGER VAR. NIGER) ASPERGILLUS NIGER VAR. NIGER 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0032-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0032-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0032-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0032-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0032-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
ASPERGILLUS FLAVUS aspergillus flavus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0624
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPERGILLUS FLAVUS (ASPERGILLUS FLAVUS) ASPERGILLUS FLAVUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0624-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0624-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0624-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0624-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0624-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHOPHYTON SCHOENLEINII trichophyton schoenleinii injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0618
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON SCHOENLEINII (TRICHOPHYTON SCHOENLEINII) TRICHOPHYTON SCHOENLEINII 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0618-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0618-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0618-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0618-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0618-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ALTERNARIA ALTERNATA alternaria alternata injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0001
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0001-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0001-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0001-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0001-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0001-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
ACROTHECIUM ROBUSTUM acrothecium robustum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0620
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACROTHECIUM ROBUSTUM (ACROTHECIUM ROBUSTUM) ACROTHECIUM ROBUSTUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0620-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0620-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0620-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0620-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0620-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
ABSIDIA RAMOSA absidia ramosa injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0619
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOCLADUS CORYMBIFERUS (MYCOCLADUS CORYMBIFERUS) MYCOCLADUS CORYMBIFERUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0619-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0619-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0619-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0619-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0619-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CEPHALOTHECIUM cephalothecium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0095
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOTHECIUM ROSEUM (TRICHOTHECIUM ROSEUM) TRICHOTHECIUM ROSEUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0095-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0095-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0095-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0095-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0095-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
CHAETOMIUM chaetomium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0093
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHAETOMIUM GLOBOSUM (CHAETOMIUM GLOBOSUM) CHAETOMIUM GLOBOSUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0093-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0093-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0093-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0093-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0093-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
CURVULARIA curvularia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0097
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCHLIOBOLUS SPICIFER (COCHLIOBOLUS SPICIFER) COCHLIOBOLUS SPICIFER 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0097-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0097-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0097-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0097-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0097-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
CLADOSPORIUM FULVUM cladosporium fulvum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0096
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PASSALORA FULVA (PASSALORA FULVA) PASSALORA FULVA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0096-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0096-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0096-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0096-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0096-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
BERMUDA GRASS SMUT bermuda grass smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0064
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO CYNODONTIS (USTILAGO CYNODONTIS) USTILAGO CYNODONTIS 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0064-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0064-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0064-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0064-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0064-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
BOTRYTIS botrytis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0038
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOTRYTIS CINEREA (BOTRYTIS CINEREA) BOTRYTIS CINEREA 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
SODIUM CHLORIDE 0.0095 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0038-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0038-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0038-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0038-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0038-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
CEPHALOSPORIUM cephalosporium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0087
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACREMONIUM STRICTUM (ACREMONIUM STRICTUM) ACREMONIUM STRICTUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0087-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0087-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0087-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0087-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0087-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
BARLEY SMUT barley smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0066
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO NUDA HORDEI (USTILAGO NUDA HORDEI) USTILAGO NUDA HORDEI 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0066-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0066-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0066-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0066-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0066-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SPONDYLOCLADIUM spondylocladium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0464
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLLETOTRICHUM COCCODES (COLLETOTRICHUM COCCODES) COLLETOTRICHUM COCCODES 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0464-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0464-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0464-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0464-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0464-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
SCOPULARIOPSIS scopulariopsis injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0463
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICROASCUS BREVICAULIS (MICROASCUS BREVICAULIS) MICROASCUS BREVICAULIS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0463-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0463-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0463-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0463-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0463-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STREPTOMYCES streptomyces injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0468
Route of Administration SUBCONJUNCTIVAL, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STREPTOMYCES GRISEUS (STREPTOMYCES GRISEUS) STREPTOMYCES GRISEUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0468-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0468-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0468-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0468-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0468-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STEMPHYLIUM stemphylium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0466
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PLEOSPORA HERBARUM (PLEOSPORA HERBARUM) PLEOSPORA HERBARUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0466-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0466-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0466-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0466-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0466-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
RHIZOPUS rhizopus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0434
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0434-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0434-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0434-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0434-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0434-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
PENICILLIUM ITALICUM penicillium italicum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0651
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM ITALICUM (PENICILLIUM ITALICUM) PENICILLIUM ITALICUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0651-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0651-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0651-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0651-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0651-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
SACCHAROMYCES saccharomyces injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0462
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SACCHAROMYCES CEREVISIAE (SACCHAROMYCES CEREVISIAE) SACCHAROMYCES CEREVISIAE 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0462-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0462-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0462-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0462-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0462-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
RHODOTORULA rhodotorula injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0436
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHODOTORULA RUBRA (RHODOTORULA RUBRA) RHODOTORULA RUBRA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0436-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0436-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0436-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0436-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0436-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHOPHYTON RUBRUM trichophyton rubrum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0579
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON RUBRUM (TRICHOPHYTON RUBRUM) TRICHOPHYTON RUBRUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0579-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0579-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0579-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0579-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0579-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
TETRACOCCOSPORIUM PAXIANUM tetracoccosporium paxianum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0564
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACOCCOSPORIUM PAXIANUM (TETRACOCCOSPORIUM PAXIANUM) TETRACOCCOSPORIUM PAXIANUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0564-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0564-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0564-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0564-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0564-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
VERTICILLIUM verticillium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0594
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VERTICILLIUM ALBO-ATRUM (VERTICILLIUM ALBO-ATRUM) VERTICILLIUM ALBO-ATRUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0594-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0594-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0594-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0594-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0594-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0585
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHOPHYTON MENTAGROPHYTES (TRICHOPHYTON MENTAGROPHYTES) TRICHOPHYTON MENTAGROPHYTES 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0585-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0585-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0585-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0585-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0585-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
STACHYBOTRYS stachybotrys injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0470
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STACHYBOTRYS CHARTARUM (STACHYBOTRYS CHARTARUM) STACHYBOTRYS CHARTARUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0470-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0470-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0470-3 5 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0470-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0470-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
SPOROTRICHUM sporotrichum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0469
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SPOROTRICHUM PRUINOSUM (SPOROTRICHUM PRUINOSUM) SPOROTRICHUM PRUINOSUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0469-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0469-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0469-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0469-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0469-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
TRICHODERMA trichoderma injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0562
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICHODERMA VIRIDE (TRICHODERMA VIRIDE) TRICHODERMA VIRIDE 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0562-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0562-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0562-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0562-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0562-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
SYNCEPHALASTRUM syncephalastrum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0472
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SYNCEPHALASTRUM RACEMOSUM (SYNCEPHALASTRUM RACEMOSUM) SYNCEPHALASTRUM RACEMOSUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0472-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0472-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0472-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0472-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0472-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
OAT SMUT oat smut injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0342
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
USTILAGO AVENAE (USTILAGO AVENAE) USTILAGO AVENAE 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0342-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0342-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0342-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0342-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0342-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NIGROSPORA nigrospora injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0327
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KHUSKIA ORYZAE (KHUSKIA ORYZAE) KHUSKIA ORYZAE 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0327-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0327-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0327-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0327-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0327-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
PULLULARIA pullularia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0367
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0367-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0367-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0367-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0367-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0367-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
PHOMA phoma injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0365
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0365-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0365-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0365-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0365-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0365-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
MUCOR MUCEDO mucor mucedo injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0637
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0637-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0637-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0637-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0637-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0637-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NEUROSPORA INTERMEDIA neurospora intermedia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0326
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA INTERMEDIA (NEUROSPORA INTERMEDIA) NEUROSPORA INTERMEDIA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0326-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0326-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0326-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0326-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0326-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
NEUROSPORA CRASSA neurospora crassa injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0639
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEUROSPORA CRASSA (NEUROSPORA CRASSA) NEUROSPORA CRASSA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0639-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0639-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0639-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0639-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0639-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
MUCOR PLUMBEUS mucor plumbeus injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0638
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0638-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0638-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0638-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0638-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0638-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PENICILLIUM CAMEMBERTII penicillium camembertii injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0648
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CAMEMBERTI (PENICILLIUM CAMEMBERTI) PENICILLIUM CAMEMBERTI 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0648-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0648-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0648-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0648-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0648-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PENICILLIUM ROQUEFORTII penicillium roquefortii injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0647
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0647-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0647-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0647-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0647-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0647-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PENICILLIUM EXPANSUM penicillium expansum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0650
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM EXPANSUM (PENICILLIUM EXPANSUM) PENICILLIUM EXPANSUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0650-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0650-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0650-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0650-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0650-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PENICILLIUM CHRYSOGENUM penicillium chrysogenum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0649
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0649-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0649-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0649-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0649-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0649-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PAPULARIA papularia injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0372
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
APIOSPORA MONTAGNEI (APIOSPORA MONTAGNEI) APIOSPORA MONTAGNEI 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
SODIUM CHLORIDE 0.0095 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0372-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0372-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0372-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0372-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0372-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
PAECILOMYCES paecilomyces injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0370
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAECILOMYCES VARIOTII (PAECILOMYCES VARIOTII) PAECILOMYCES VARIOTII 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
WATER
SODIUM BICARBONATE 0.0024 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0370-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0370-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0370-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0370-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0370-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
PENICILLIUM NOTATUM penicillium notatum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0416
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0416-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0416-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0416-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0416-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0416-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
PHYCOMYCES phycomyces injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0373
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYCOMYCES BLAKESLEEANUS (PHYCOMYCES BLAKESLEEANUS) PHYCOMYCES BLAKESLEEANUS 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0373-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0373-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0373-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0373-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0373-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
HUMICOLA GRISEA humicola grisea injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0635
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMICOLA GRISEA (HUMICOLA GRISEA) HUMICOLA GRISEA 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0635-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0635-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0635-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0635-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0635-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
C MOLD MIXTURE c mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0090
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOCLADUS CORYMBIFERUS (MYCOCLADUS CORYMBIFERUS) MYCOCLADUS CORYMBIFERUS 0.0083 g in 1 mL
ACROTHECIUM ROBUSTUM (ACROTHECIUM ROBUSTUM) ACROTHECIUM ROBUSTUM 0.0083 g in 1 mL
HUMICOLA GRISEA (HUMICOLA GRISEA) HUMICOLA GRISEA 0.0083 g in 1 mL
MICROSPORUM AUDOUINII (MICROSPORUM AUDOUINII) MICROSPORUM AUDOUINII 0.0083 g in 1 mL
MICROSPORUM CANIS (MICROSPORUM CANIS) MICROSPORUM CANIS 0.0083 g in 1 mL
APIOSPORA MONTAGNEI (APIOSPORA MONTAGNEI) APIOSPORA MONTAGNEI 0.0083 g in 1 mL
PHYCOMYCES BLAKESLEEANUS (PHYCOMYCES BLAKESLEEANUS) PHYCOMYCES BLAKESLEEANUS 0.0083 g in 1 mL
SPOROTRICHUM PRUINOSUM (SPOROTRICHUM PRUINOSUM) SPOROTRICHUM PRUINOSUM 0.0083 g in 1 mL
STACHYBOTRYS CHARTARUM (STACHYBOTRYS CHARTARUM) STACHYBOTRYS CHARTARUM 0.0083 g in 1 mL
SYNCEPHALASTRUM RACEMOSUM (SYNCEPHALASTRUM RACEMOSUM) SYNCEPHALASTRUM RACEMOSUM 0.0083 g in 1 mL
TETRACOCCOSPORIUM PAXIANUM (TETRACOCCOSPORIUM PAXIANUM) TETRACOCCOSPORIUM PAXIANUM 0.0083 g in 1 mL
VERTICILLIUM ALBO-ATRUM (VERTICILLIUM ALBO-ATRUM) VERTICILLIUM ALBO-ATRUM 0.0083 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0090-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0090-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0090-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0090-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0090-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 04/13/1992
C MOLD MIXTURE c mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0091
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOCLADUS CORYMBIFERUS (MYCOCLADUS CORYMBIFERUS) MYCOCLADUS CORYMBIFERUS 0.0042 g in 1 mL
ACROTHECIUM ROBUSTUM (ACROTHECIUM ROBUSTUM) ACROTHECIUM ROBUSTUM 0.0042 g in 1 mL
HUMICOLA GRISEA (HUMICOLA GRISEA) HUMICOLA GRISEA 0.0042 g in 1 mL
MICROSPORUM AUDOUINII (MICROSPORUM AUDOUINII) MICROSPORUM AUDOUINII 0.0042 g in 1 mL
MICROSPORUM CANIS (MICROSPORUM CANIS) MICROSPORUM CANIS 0.0042 g in 1 mL
APIOSPORA MONTAGNEI (APIOSPORA MONTAGNEI) APIOSPORA MONTAGNEI 0.0042 g in 1 mL
PHYCOMYCES BLAKESLEEANUS (PHYCOMYCES BLAKESLEEANUS) PHYCOMYCES BLAKESLEEANUS 0.0042 g in 1 mL
SPOROTRICHUM PRUINOSUM (SPOROTRICHUM PRUINOSUM) SPOROTRICHUM PRUINOSUM 0.0042 g in 1 mL
STACHYBOTRYS CHARTARUM (STACHYBOTRYS CHARTARUM) STACHYBOTRYS CHARTARUM 0.0042 g in 1 mL
SYNCEPHALASTRUM RACEMOSUM (SYNCEPHALASTRUM RACEMOSUM) SYNCEPHALASTRUM RACEMOSUM 0.0042 g in 1 mL
TETRACOCCOSPORIUM PAXIANUM (TETRACOCCOSPORIUM PAXIANUM) TETRACOCCOSPORIUM PAXIANUM 0.0042 g in 1 mL
VERTICILLIUM ALBO-ATRUM (VERTICILLIUM ALBO-ATRUM) VERTICILLIUM ALBO-ATRUM 0.0042 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0091-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0091-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0091-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0091-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0091-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
C MOLD MIXTURE c mold mixture injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0092
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOCLADUS CORYMBIFERUS (MYCOCLADUS CORYMBIFERUS) MYCOCLADUS CORYMBIFERUS 0.0021 g in 1 mL
ACROTHECIUM ROBUSTUM (ACROTHECIUM ROBUSTUM) ACROTHECIUM ROBUSTUM 0.0021 g in 1 mL
HUMICOLA GRISEA (HUMICOLA GRISEA) HUMICOLA GRISEA 0.0021 g in 1 mL
MICROSPORUM AUDOUINII (MICROSPORUM AUDOUINII) MICROSPORUM AUDOUINII 0.0021 g in 1 mL
MICROSPORUM CANIS (MICROSPORUM CANIS) MICROSPORUM CANIS 0.0021 g in 1 mL
APIOSPORA MONTAGNEI (APIOSPORA MONTAGNEI) APIOSPORA MONTAGNEI 0.0021 g in 1 mL
PHYCOMYCES BLAKESLEEANUS (PHYCOMYCES BLAKESLEEANUS) PHYCOMYCES BLAKESLEEANUS 0.0021 g in 1 mL
SPOROTRICHUM PRUINOSUM (SPOROTRICHUM PRUINOSUM) SPOROTRICHUM PRUINOSUM 0.0021 g in 1 mL
STACHYBOTRYS CHARTARUM (STACHYBOTRYS CHARTARUM) STACHYBOTRYS CHARTARUM 0.0021 g in 1 mL
SYNCEPHALASTRUM RACEMOSUM (SYNCEPHALASTRUM RACEMOSUM) SYNCEPHALASTRUM RACEMOSUM 0.0021 g in 1 mL
TETRACOCCOSPORIUM PAXIANUM (TETRACOCCOSPORIUM PAXIANUM) TETRACOCCOSPORIUM PAXIANUM 0.0021 g in 1 mL
VERTICILLIUM ALBO-ATRUM (VERTICILLIUM ALBO-ATRUM) VERTICILLIUM ALBO-ATRUM 0.0021 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 0.525 mL in 1 mL
SODIUM CHLORIDE 0.0095 g in 1 mL
SODIUM BICARBONATE 0.0024 g in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0092-1 2 mL in 1 VIAL, MULTI-DOSE None
2 NDC:49288-0092-2 5 mL in 1 VIAL, MULTI-DOSE None
3 NDC:49288-0092-3 10 mL in 1 VIAL, MULTI-DOSE None
4 NDC:49288-0092-4 30 mL in 1 VIAL, MULTI-DOSE None
5 NDC:49288-0092-5 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 03/23/1974
Labeler — Antigen Laboratories, Inc. (030705628)
Registrant — Antigen Laboratories, Inc. (030705628)
Establishment
Name Address ID/FEI Operations
Antigen Laboratories, Inc. 030705628 manufacture

Revised: 11/2009 Antigen Laboratories, Inc.

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