GLATIRAMER ACETATE injection, solution

GLATIRAMER ACETATE by

Drug Labeling and Warnings

GLATIRAMER ACETATE by is a Prescription medication manufactured, distributed, or labeled by Italfarmaco SpA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 11797-764-03

ONCE DAILY

Glatiramer Acetate
Injection

20
mg/mL

FOR SUBCUTANEOUS INJECTION ONLY

30 pre-filled syringe (3 carton box of 10 syringes)

Each pre-filled syringe contains 1 mL Glatiramer Acetate Injection
solution of: glatiramer acetate 20 mg, mannitol 40 mg (inactive ingredient).
Dispense the enclosed Medication Guide to each patient

zydus
Pharmaceuticals
USA

Rx only

NDC: 11797-765-03

THREE TIMES A WEEK

Glatiramer Acetate
Injection

40
mg/mL

FOR SUBCUTANEOUS INJECTION ONLY

12 Single Dose Pre-Filled Syringes

Each pre-filled syringe contains 1 mL Glatiramer Acetate Injection
solution of: glatiramer acetate 40 mg, mannitol 40 mg (inactive ingredient).
Dispense the enclosed Medication Guide to each patient

zydus
Pharmaceuticals
USA

Rx only

INGREDIENTS AND APPEARANCE

GLATIRAMER ACETATE 
glatiramer acetate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 11797-764
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLATIRAMER ACETATE (UNII: 5M691HL4BO) (GLATIRAMER - UNII:U782C039QP)	GLATIRAMER ACETATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)	40 mg  in 1 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11797-764-03	30 in 1 CARTON	11/10/2025
1		1 mL in 1 SYRINGE; 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
ANDA	ANDA208468	11/10/2025

GLATIRAMER ACETATE 
glatiramer acetate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 11797-765
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLATIRAMER ACETATE (UNII: 5M691HL4BO) (GLATIRAMER - UNII:U782C039QP)	GLATIRAMER ACETATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)	40 mg  in 1 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11797-765-03	12 in 1 CARTON	11/10/2025
1		1 mL in 1 SYRINGE; 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
ANDA	ANDA208468	11/10/2025

Labeler - Italfarmaco SpA (428179329)

Establishment
Name	Address	ID/FEI	Business Operations
Italfarmaco SpA		428179329	MANUFACTURE(11797-764, 11797-765) , ANALYSIS(11797-764, 11797-765) , PACK(11797-764, 11797-765)