Home DailyMed 1b3a60de-2191-4b15-be69-01329da87711 GLATIRAMER ACETATE injection, for subcutaneous use Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Italfarmaco SpA
Effective date 2025-10-31
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-05-31 22:04:50 Label at a glance# Product GLATIRAMER ACETATE
Active ingredient GLATIRAMER ACETATE
Label structure 1 sections
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 1111641 glatiramer acetate 20 MG in 1 ML Prefilled Syringe PSN 1 1487361 glatiramer acetate 40 MG/ML in 1 ML Prefilled Syringe PSN 1 1111641 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe SCD 1 1487361 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe SCD 1 1111641 glatiramer acetate 20 MG per 1 ML Prefilled Syringe SY 1 1487361 glatiramer acetate 40 MG/ML per 1 ML Prefilled Syringe SY 1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11797-764-03 GLATIRAMER ACETATE 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 1 11797-764-03 GLATIRAMER ACETATE 30 in 1 CARTON INJECTION, SOLUTION 30 1 11797-765-03 GLATIRAMER ACETATE 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 1 11797-765-03 GLATIRAMER ACETATE 12 in 1 CARTON INJECTION, SOLUTION 12 1
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 4 matching rows.
GLATIRAMER ACETATE GLATIRAMER MANNITOL WATER Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 6 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208468-001 GLATIRAMER ACETATE GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 A208468-002 GLATIRAMER ACETATE GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A208468-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208468-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208468-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208468-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208468-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208468-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208468-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208468-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208468-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208468-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208468-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208468-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208468-001 GLATIRAMER ACETATE 20MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208468-002 GLATIRAMER ACETATE 40MG/ML INJECTABLE / SUBCUTANEOUS AP 2025-05-07 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.