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ALKERAN

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
melphalan hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63379-018
Packaging
# Item Code Package Description
1 NDC:63379-018-00 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-DOSE 10 mL
Part 2 1 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 Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELPHALAN HYDROCHLORIDE (MELPHALAN) MELPHALAN 50 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
Packaging
# Item Code Package Description
1 NDC:63379-019-00 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020207 01/01/2011
Part 2 of 2
DILUENT
water injection
Product Information
Item Code (Source) NDC:63379-020
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CITRATE, UNSPECIFIED FORM
PROPYLENE GLYCOL
ALCOHOL
Packaging
# Item Code Package Description
1 NDC:63379-020-00 10 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020207 01/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA020207 01/01/2011
Labeler - Glaxo Operations UK Ltd (424738227)
Glaxo Operations UK Ltd

Medically reviewed by Drugs.com. Last updated on Oct 22, 2020.

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