FDA.reportPublic FDA data

1 ML glatiramer acetate 20 MG/ML Prefilled Syringe

RxCUI
1111641
RxNorm name
1 ML glatiramer acetate 20 MG/ML Prefilled Syringe
Display name
1 ML glatiramer acetate 20 MG/ML Prefilled Syringe
Full name
1 ML glatiramer acetate 20 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CopaxoneGLATIRAMER ACETATETeva Neuroscience, Inc.aa88f583-4f5f-433b-80b4-1f4c9fb283572026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
Glatiramer AcetateGLATIRAMER ACETATEAJENAT PHARMACEUTICALS LLC7a573ffb-5dd7-43b7-8633-c69f303b1bbf2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
Glatiramer AcetateGLATIRAMER ACETATE INJECTIONUPSHER-SMITH LABORATORIES, LLC707a64ef-964e-44a3-8a0f-fcc2eb5b1af22026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
GLATIRAMER ACETATEGLATIRAMER ACETATEZydus Pharmaceuticals USA Inc.0aa4ff2a-ce8e-46cd-830f-a264cc582be22025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
GLATIRAMER ACETATEGLATIRAMER ACETATEItalfarmaco SpA1b3a60de-2191-4b15-be69-01329da877112025-10-31Exact identifier
rxcui: 1111641
GlatopaGLATIRAMER ACETATEBryant Ranch Prepack0679689e-8930-4d6a-b922-5125082b27162025-03-27Warnings, Adverse reactionsExact identifier
rxcui: 1111641
Glatiramer AcetateGLATIRAMER ACETATESun Pharmaceutical Industries, Inc.f90cc5f5-56a1-48dc-a4fc-0ae89ef61deb2025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
Glatiramer AcetateGLATIRAMER ACETATEMylan Pharmaceuticals Inc.f38b5606-d2d7-44ec-912f-46882aa2fa7b2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641
GlatopaGLATIRAMER ACETATESandoz Inc5f01e40a-b6f6-40fb-b37c-3d06f1428e862025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1111641

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
0679689e-8930-4d6a-b922-5125082b2716glatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]3103These highlights do not include all the information needed to use GLATOPA ® safely and effectively. See full prescribing information for GLATOPA . GLATOPA (glatiramer acetate injection), for subcutaneous use Initial U.S. Approval: 199620250327
aa88f583-4f5f-433b-80b4-1f4c9fb28357glatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]335These highlights do not include all the information needed to use COPAXONE ® safely and effectively. See full prescribing information for COPAXONE. COPAXONE (glatiramer acetate injection), for subcutaneous use Initial U.S. Approval: 199620250131
5f01e40a-b6f6-40fb-b37c-3d06f1428e86glatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]328These highlights do not include all the information needed to use GLATOPA safely and effectively. See full prescribing information for GLATOPA . GLATOPA ® (glatiramer acetate injection), for subcutaneous use Initial U.S. Approval: 199620250206
f38b5606-d2d7-44ec-912f-46882aa2fa7bglatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]314These highlights do not include all the information needed to use GLATIRAMER ACETATE INJECTION safely and effectively. See full prescribing information for GLATIRAMER ACETATE INJECTION. GLATIRAMER ACETATE injection, for subcutaneous use Initial U.S. Approval: 199620250207
707a64ef-964e-44a3-8a0f-fcc2eb5b1af2glatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]38These highlights do not include all the information needed to use GLATIRAMER ACETATE INJECTION safely and effectively. See full prescribing information for GLATIRAMER ACETATE INJECTION. GLATIRAMER ACETATE injection for subcutaneous use. Initial U.S. Approval: 199620260115
f90cc5f5-56a1-48dc-a4fc-0ae89ef61debglatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]38These highlights do not include all the information needed to use GLATIRAMER ACETATE injection safely and effectively. See full prescribing information for GLATIRAMER ACETATE injection. GLATIRAMER ACETATE injection, for subcutaneous use Initial U.S. Approval: 199620250220
7a573ffb-5dd7-43b7-8633-c69f303b1bbfglatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]32These highlights do not include all the information needed to use GLATIRAMER ACETATE INJECTION safely and effectively. See full prescribing information for GLATIRAMER ACETATE INJECTION. GLATIRAMER ACETATE injection, for subcutaneous use Initial U.S. Approval: 199620260331
0aa4ff2a-ce8e-46cd-830f-a264cc582be2glatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]31These highlights do not include all the information needed to use GLATIRAMER ACETATE INJECTION safely and effectively. See full prescribing information for GLATIRAMER ACETATE INJECTION. GLATIRAMER ACETATE injection, for subcutaneous use Initial U.S. Approval: 199620251104
1b3a60de-2191-4b15-be69-01329da87711glatiramer acetate 20 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 20 MG per 1 ML Prefilled Syringe [SY]31GLATIRAMER ACETATE injection, for subcutaneous use20251031