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Alkeran Prescribing Information

Package insert / product label
Generic name: melphalan hydrochloride
Dosage form: injection
Drug class: Alkylating agents

Medically reviewed by Drugs.com. Last updated on Oct 4, 2023.

Principal Display Panel

NDC 52609-3001-0

ALKERAN®

(melphalan hydrochloride)

for Injection

SINGLE-USE

Rx only

One vial of Alkeran for injection containing sterile, nonpyrogenic, freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and 20 mg povidone.

One vial of sterile, nonpyrogenic diluent containing 0.2 g sodium citrate, 6.0 mL propylene glycol, 0.52 mL ethanol (96%), and Water for Injection to a total of 10 mL.

For Intravenous Infusion.

Reconstitute with enclosed diluent. See enclosed package insert for additional reconstitution and administration instructions.

See prescribing information for Dosage and Administration.

Store at controlled room temperature, 15o to 30oC (59o to 86oF) and protect from light.

Add diluent rapidly.

Immediately shake vial vigorously.

ALKERAN and Diluent

Manufactured by: GlaxoSmithKline

Research Triangle Park, NC 27709

Distributed by: ApoPharma USA Inc

Rockville, MD 20850

10000000101311 Rev. 11/11

Alkeran for Injection ApoPharma vial carton
ALKERAN
melphalan hydrochloride kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-018
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-018-001 in 1 CARTON; Type 0: Not a Combination Product01/01/2011
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, SINGLE-DOSE 10 mL
Part 21 VIAL, SINGLE-USE 10 mL
Part 1 of 2
ALKERAN
melphalan hydrochloride injection, powder, for solution
Product Information
Item Code (Source)NDC:63379-019
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MELPHALAN HYDROCHLORIDE (UNII: 1VXP4V453T) (MELPHALAN - UNII:Q41OR9510P) MELPHALAN50 mg in 10 mL
Inactive Ingredients
Ingredient NameStrength
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-019-0010 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02020701/01/2011
Part 2 of 2
DILUENT
water injection
Product Information
Item Code (Source)NDC:63379-020
Route of AdministrationINTRAVENOUS
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-020-0010 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02020701/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02020701/01/2011
Labeler - Glaxo Operations UK Ltd (424738227)