GLATIRAMER ACETATE injection, for subcutaneous use

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#

ProductGLATIRAMER ACETATE
Active ingredientGLATIRAMER ACETATE
Label structure1 sections

Label contents#

Full prescribing information#

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
20 mg container label

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
20 mg container label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111641glatiramer acetate 20 MG in 1 ML Prefilled SyringePSN1
1487361glatiramer acetate 40 MG/ML in 1 ML Prefilled SyringePSN1
11116411 ML glatiramer acetate 20 MG/ML Prefilled SyringeSCD1
14873611 ML glatiramer acetate 40 MG/ML Prefilled SyringeSCD1
1111641glatiramer acetate 20 MG per 1 ML Prefilled SyringeSY1
1487361glatiramer acetate 40 MG/ML per 1 ML Prefilled SyringeSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ee46d8-7228-4160-88ad-868cc5abf72fProduct name520260223
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11797-764-03GLATIRAMER ACETATE1 mL in 1 SYRINGEINJECTION, SOLUTION11
11797-764-03GLATIRAMER ACETATE30 in 1 CARTONINJECTION, SOLUTION301
11797-765-03GLATIRAMER ACETATE1 mL in 1 SYRINGEINJECTION, SOLUTION11
11797-765-03GLATIRAMER ACETATE12 in 1 CARTONINJECTION, SOLUTION121

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11797-76411797-764-03
11797-76511797-765-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208468-001GLATIRAMER ACETATEGLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07
A208468-002GLATIRAMER ACETATEGLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A208468-001AP
A208468-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208468-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07c2088c7a36db…
2026-10-15 13:18:302026-09A208468-002GLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07c2088c7a36db…
2026-09-14 22:38:342026-08A208468-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-0784e616aacf4f…
2026-09-14 22:38:342026-08A208468-002GLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-0784e616aacf4f…
2026-08-18 06:07:402026-07A208468-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A208468-002GLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208468-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208468-002GLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208468-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208468-002GLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208468-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208468-002GLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-076a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208468-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208468-002GLATIRAMER ACETATE40MG/MLINJECTABLE / SUBCUTANEOUSAP2025-05-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A208468-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09A208468-002AP1c2088c7a36db…
2026-09-14 22:38:342026-08A208468-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A208468-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A208468-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A208468-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208468-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208468-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208468-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208468-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208468-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208468-002AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208468-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208468-002AP1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLATIRAMER ACETATEGLATIRAMER ACETATEItalfarmaco SpA1b3a60de-2191-4b15-be69-01329da877112025-10-31Exact identifier
ndc (package): 11797-765-03
ndc (package): 11797-764-03
ndc (product): 11797-765
ndc (product): 11797-764
ndc11 (package): 11797076403
ndc11 (package): 11797076503
spl id: 1bf557de-bcff-476b-b7c3-c7f7b8ddbfb2
spl set id: 1b3a60de-2191-4b15-be69-01329da87711

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.