Standardized Orchard Grass Pollen (Page 4 of 4)

HOW SUPPLIED

Diagnostic Allergens:

Scratch or Prick test:

10,000 BAU/mL or 100,000 BAU/mL contained in

50% glycerin (v/v)

in 5mL dropper vials.

Intradermal test:

100 BAU/mL in 5mL or 10mL sterile multiple dose vials.

Concentrate of Extract for Therapeutic Use Allergens:

10,000 BAU/mL and 100,000 BAU/mL are supplied in 5mL, 10mL, 50mL multiple dose vials.

STORAGE

The expiration date of Standardized Pollen extract containing 10,000 BAU/mL or 100,000 BAU/mL in 50% glycerin (v/v) is listed on the container label. Store extracts upon arrival at 2° to 8 °C and keep them in this range during office use.

WARRANTY We warrant that this product was prepared and tested according to the standards of the FDA and is true to label. Because of biological differences in individuals and because allergenic extracts are manufactured to be potent and because we have no control over the conditions of use, we cannot and do not warrant either a good effect or against an ill effect following use.

REFERENCES

1. Jacobs, Robert L., Geoffrey W.Rake,Jr., et.al. Potentiated Anaphylaxis in Patients with Drug-induced Beta-adrenergic Blockade. J.Allergy & Clin. Immunol., 68(2): 125-127. August 1981.

2. Turkeltaub,P., Rastogi,S. Quantitative Intradermal Procedure for Evaluation of Subject Sensitivity to Standardized Allergenic Extracts and for Assignment of Bioequivalent Allergy Units to Reference Preparations using ID50EAL. Methods & Procedures Manual, CBER,1993.

3. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

4. Murray,A.B., Ferguson,A., Morrison, B., The frequency and severity of cat allergy vs dog allergy in atopic children. J. Allergy Clin. Immunolo: 72, 145-9, 1983.

5. Reid,M.J., Lockey,R.F., Turkeltaub,P.C., Platts-Mills,T.A.E., Survey of fatalities from skin testing and immunotherapy 1985-1989. Journal of Allergy Clin. Immunol. 92 (1): 6-15, July 1993.

CONTAINER LABELING

5 mL Std Grass Scratch
(click image for full-size original)
Mixed Std Grass Therapeutic
(click image for full-size original)
Std Grass Intradermal
(click image for full-size original)
Std Grass Therapeutic
(click image for full-size original)
STANDARDIZED ORCHARD GRASS POLLEN standardized orchard grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2346
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) DACTYLIS GLOMERATA POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2346-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2346-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2346-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2346-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102198 02/10/1998
STANDARDIZED PERENNIAL RYE GRASS POLLEN standardized perennial rye grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2390
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOLIUM PERENNE POLLEN (LOLIUM PERENNE POLLEN) LOLIUM PERENNE POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2390-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2390-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2390-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2390-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102200 02/10/1998
STANDARDIZED TIMOTHY GRASS POLLEN standardized timothy grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2402
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) PHLEUM PRATENSE POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2402-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2402-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2402-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2402-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102202 02/10/1998
STANDARDIZED REDTOP GRASS POLLEN standardized redtop grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2364
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2364-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2364-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2364-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2364-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 02/10/1998
STANDARDIZED KENTUCKY (JUNE) BLUEGRASS POLLEN standardized kentucky (june) bluegrass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2428
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2428-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2428-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2428-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2428-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102196 02/10/1998
STANDARDIZED MEADOW FESCUE GRASS POLLEN standardized meadow fescue grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2320
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESTUCA PRATENSIS POLLEN (FESTUCA PRATENSIS POLLEN) FESTUCA PRATENSIS POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2320-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2320-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2320-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2320-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102197 02/10/1998
STANDARDIZED SWEET VERNAL GRASS POLLEN standardized sweet vernal grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2400
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTHOXANTHUM ODORATUM POLLEN (ANTHOXANTHUM ODORATUM POLLEN) ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
SODIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2400-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2400-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2400-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2400-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102201 02/10/1998
STANDARDIZED BERMUDA GRASS POLLEN standardized bermuda grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2270
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON POLLEN (CYNODON DACTYLON POLLEN) CYNODON DACTYLON POLLEN 10000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2270-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2270-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2270-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2270-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102195 02/10/1998
STANDARDIZED ORCHARD GRASS POLLEN standardized orchard grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2345
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) DACTYLIS GLOMERATA POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2345-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2345-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2345-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2345-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102198 02/10/1998
STANDARDIZED PERENNIAL RYE GRASS POLLEN standardized perennial rye grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2389
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOLIUM PERENNE POLLEN (LOLIUM PERENNE POLLEN) LOLIUM PERENNE POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2389-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2389-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2389-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2389-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102200 02/10/1998
STANDARDIZED TIMOTHY GRASS POLLEN standardized timothy grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2401
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) PHLEUM PRATENSE POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2401-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2401-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2401-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2401-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102202 02/10/1998
STANDARDIZED REDTOP GRASS POLLEN standardized redtop grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2363
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGROSTIS GIGANTEA POLLEN (AGROSTIS GIGANTEA POLLEN) AGROSTIS GIGANTEA POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2363-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2363-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2363-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2363-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102192 02/10/1998
STANDARDIZED KENTUCKY (JUNE) BLUEGRASS POLLEN standardized kentucky (june) bluegrass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2427
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2427-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2427-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2427-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2427-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102196 02/10/1998
STANDARDIZED MEADOW FESCUE GRASS POLLEN standardized meadow fescue grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2319
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FESTUCA PRATENSIS POLLEN (FESTUCA PRATENSIS POLLEN) FESTUCA PRATENSIS POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2319-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2319-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2319-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2319-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102197 02/10/1998
STANDARDIZED SWEET VERNAL GRASS POLLEN standardized sweet vernal grass pollen injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2399
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTHOXANTHUM ODORATUM POLLEN (ANTHOXANTHUM ODORATUM POLLEN) ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
PHENOL
SODIUM CHLORIDE
SODIUM BICARBONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2399-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2399-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2399-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2399-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102201 02/10/1998
Labeler — Nelco Laboratories, Inc. (054980867)
Registrant — Nelco Laboratories, Inc. (054980867)
Establishment
Name Address ID/FEI Operations
Nelco Laboratories, Inc. 054980867 manufacture

Revised: 11/2009 Nelco Laboratories, Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.