Glatiramer Acetate Injection, Solution
FDA Label NDC 11797-765

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Italfarmaco Spa for the product Glatiramer Acetate (NDC 11797-765). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

20 mg Container Label (Glatiramer 01)

20 mg Container Label (Glatiramer 01)

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

20 mg Container Label (Glatiramer 02)

20 mg Container Label (Glatiramer 02)

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