icians Total Care, Inc.
Tulsa, Oklahoma 74146
Principal Display Panel
ALKERAN®
(melphalan)
Tablets 2 mg
Each tablet contains 2 mg melphalan.
Rx only
WARNING: This drug is only to be taken under close medical supervision. Do not take in larger doses or more frequently or for a longer time than specifically directed by the physician. Periodic blood counts are necessary to determine proper dose and to avoid ill effects.
See prescribing information for Dosage and Administration.
Store in a refrigerator, 2o to 8oC (36o to 46oF). Protect from light.
Dispense in glass, tight, light-resistant container as defined in the USP.
ALKERAN
melphalan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4339(NDC:0173-0045)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELPHALAN (MELPHALAN) MELPHALAN 2 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
POLYETHYLENE GLYCOL 400
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code GX;EH3;A
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:54868-4339-0 4 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
2 NDC:54868-4339-1 50 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
3 NDC:54868-4339-3 28 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
4 NDC:54868-4339-4 32 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA014691 08/15/2005 06/30/2012
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack
Revised: 09/2012 Physicians Total Care, Inc.
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