FDA.reportPublic FDA data

1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Copaxone]

RxCUI
1487363
RxNorm name
1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Copaxone]
Display name
1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Copaxone]
Full name
1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Copaxone]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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 · 1 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: 1487363

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
aa88f583-4f5f-433b-80b4-1f4c9fb28357Copaxone 40 MG in 1 ML Prefilled Syringe [PSN] · 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe [Copaxone] [SBD] · 1 ML Copaxone 40 MG/ML Prefilled Syringe [SY] · Copaxone 40 MG/ML 1 ML Prefilled Syringe [SY]435These 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