NDC Code(s) : 68546-317-00, 68546-317-30, 68546-325-06, 68546-325-12
Packager : Teva Neuroscience, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CopaxoneGlatiramer Acetate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-317
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLATIRAMER ACETATE(UNII: 5M691HL4BO)
(GLATIRAMER - UNII:U782C039QP) 		GLATIRAMER ACETATE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)40 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68546-317-0014 in 1 CARTON 06/04/2013
11 in 1 BLISTER PACK
11 mL in 1 SYRINGE, GLASS Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:68546-317-3030 in 1 CARTON 28/04/2008
21 in 1 BLISTER PACK
21 mL in 1 SYRINGE, GLASS Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020622 04/28/2008
CopaxoneGlatiramer Acetate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68546-325
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLATIRAMER ACETATE(UNII: 5M691HL4BO)
(GLATIRAMER - UNII:U782C039QP) 		GLATIRAMER ACETATE40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)40 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68546-325-066 in 1 CARTON 29/01/2014
11 in 1 BLISTER PACK
11 mL in 1 SYRINGE, GLASS Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:68546-325-1212 in 1 CARTON 29/01/2014
21 in 1 BLISTER PACK
21 mL in 1 SYRINGE, GLASS Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020622 01/29/2014

LABELER - Teva Neuroscience, Inc.(009906397)

PRINCIPAL DISPLAY PANEL

NDC 68546-317-30
ONCE DAILY
 COPAXONE®  (glatiramer acetate injection) 20 mg/mL
Rx Only
30 Single-Dose Pre-Filled Syringes
Each pre-filled syringe contains 1 mL COPAXONE® solution of: glatiramer acetate 20 mg; mannitol 40 mg (inactive ingredient)
FOR SUBCUTANEOUS INJECTION ONLY
Marketed by: Teva Neuroscience, Inc., Parsippany, NJ 07054
Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany NJ, 07054
Product of Israel

20mg carton

PRINCIPAL DISPLAY PANEL

NDC 68546-325-12
THREE TIMES A WEEK 
 COPAXONE®  (glatiramer acetate injection)  40  mg/mL
Rx Only
12 Single-Dose Pre-Filled Syringes
Each pre-filled syringe contains 1 mL COPAXONE® solution of: glatiramer acetate 40 mg; mannitol 40 mg (inactive ingredient)
FOR SUBCUTANEOUS INJECTION ONLY
Marketed by: Teva Neuroscience, Inc., Parsippany, NJ 07054
Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054
Product of Israel

40mg carton