Melphalan Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Melphalan Hydrochloride for Injection is supplied as a single use kit (NDC 10139-321-01) containing one single-use clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan (NDC 10139-319-10) and one 10 mL clear glass vial of sterile diluent (NDC 10139-320-01).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Manufactured for:

GeneraMedix Inc.

150 Allen Road

Liberty Corner, NJ 07938

Manufactured by:

Coldstream Laboratories, Inc

1775 McGrathiana Parkway

Lexington, KY 40511

August 2008

PI32101.01

REFERENCES

  1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
  2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services. Public Health Service publication NIH 92-2621.
  3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591.
  4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
  5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.
  6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.
  7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
  8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.

PRODUCT PACKAGING

panel
(click image for full-size original)
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10139-321
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10139-321-01 1 KIT (KIT) in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-DOSE 10 mL
Part 2 1 VIAL 10 mL
Part 1 of 2
MELAPHALAN HYDROCHLORIDE
melaphalan hydrochloride injection, powder, for solution
Product Information
Item Code (Source) NDC:10139-319
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELPHALAN HYDROCHLORIDE (MELPHALAN) MELPHALAN HYDROCHLORIDE 50 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
POVIDONE 20 mg in 10 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10139-319-10 10 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090299 10/27/2009
Part 2 of 2
DILUENT
diluent injection, solution
Product Information
Item Code (Source) NDC:10139-320
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CITRATE
PROPYLENE GLYCOL
ETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10139-320-10 10 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090299 10/27/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090299 10/27/2009
Labeler — GeneraMedix Inc. (192804032)
Establishment
Name Address ID/FEI Operations
Coldstream Laboratories Inc 794520721 manufacture

Revised: 10/2009 GeneraMedix Inc.

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