FDA.reportPublic FDA data

glatiramer acetate 40 MG/ML per 1 ML Prefilled Syringe

RxCUI
1487361
RxNorm name
glatiramer acetate 40 MG/ML per 1 ML Prefilled Syringe
Display name
glatiramer acetate 40 MG/ML per 1 ML Prefilled Syringe
Full name
glatiramer acetate 40 MG/ML per 1 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:45

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: 1487361
Glatiramer AcetateGLATIRAMER ACETATEAJENAT PHARMACEUTICALS LLC1ec10223-880d-402f-a759-9cd179bf09de2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
Glatiramer AcetateGLATIRAMER ACETATE INJECTIONUPSHER-SMITH LABORATORIES, LLC707a64ef-964e-44a3-8a0f-fcc2eb5b1af22026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
GLATIRAMER ACETATEGLATIRAMER ACETATEZydus Pharmaceuticals USA Inc.0aa4ff2a-ce8e-46cd-830f-a264cc582be22025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
GLATIRAMER ACETATEGLATIRAMER ACETATEItalfarmaco SpA1b3a60de-2191-4b15-be69-01329da877112025-10-31Exact identifier
rxcui: 1487361
GlatopaGLATIRAMER ACETATEBryant Ranch Prepack028fdf0e-2340-407b-bcd8-5a99accdddbf2025-03-27Warnings, Adverse reactionsExact identifier
rxcui: 1487361
Glatiramer AcetateGLATIRAMER ACETATESun Pharmaceutical Industries, Inc.dfacc3e2-5c91-41de-a377-873276a5cf672025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
Glatiramer AcetateGLATIRAMERMylan Pharmaceuticals Inc.456a34c7-8511-4000-99a7-ad8f8de6d35e2025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361
GlatopaGLATIRAMER ACETATESandoz Inc5f01e40a-b6f6-40fb-b37c-3d06f1428e862025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1487361

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
028fdf0e-2340-407b-bcd8-5a99accdddbfglatiramer acetate 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML 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 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML 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 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML 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
456a34c7-8511-4000-99a7-ad8f8de6d35eglatiramer acetate 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML 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 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML 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
dfacc3e2-5c91-41de-a377-873276a5cf67glatiramer acetate 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML per 1 ML Prefilled Syringe [SY]37These 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: 199620250218
1ec10223-880d-402f-a759-9cd179bf09deglatiramer acetate 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML 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 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML 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 40 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [SCD] · glatiramer acetate 40 MG/ML per 1 ML Prefilled Syringe [SY]31GLATIRAMER ACETATE injection, for subcutaneous use20251031