AN®
(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.
Made in UK
ALKERAN and Diluent
Manufactured by
GlaxoSmithKline
Research Triangle Park, NC 27709
Distributed by: ApoPharma USA Inc
Rockville, MD 20850
ALKERAN
melphalan hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52609-3001
Packaging
NDC Package Description Multilevel Packaging
1 52609-3001-0 1 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, SINGLE-USE 10 mL
Part 1 of 2
ALKERAN
melphalan hydrochloride injection, powder, for solution
Product Information
NDC Product Code (Source) 52609-3002
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
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
NDC Package Description Multilevel Packaging
1 52609-3002-0 10 mL In 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020207 01/01/2011
Part 2 of 2
DILUENT
water injection
Product Information
NDC Product Code (Source) 52609-3003
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CITRATE
PROPYLENE GLYCOL
ALCOHOL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
NDC Package Description Multilevel Packaging
1 52609-3003-0 10 mL In 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020207 01/01/2011
Marketing
