Glatiramer Acetate Injection, For Subcutaneous Use

Glatiramer Acetate Injection, For Subcutaneous Use
SPL v1
SPL
SPL Set ID 1b3a60de-2191-4b15-be69-01329da87711
Route
SUBCUTANEOUS
Published
Effective Date 2025-10-31
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glatiramer (20 mg)
Inactive Ingredients
Mannitol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-11-10
Description

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

Medication Information

Description

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

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

Structured Label Content

Package Label.principal Display Panel (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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:54:40.413087 · Updated: 2026-03-14T22:49:26.517746