FDA.reportPublic FDA data

eteplirsen 500 MG per 10 ML Injection

RxCUI
1810581
RxNorm name
eteplirsen 500 MG per 10 ML Injection
Display name
eteplirsen 500 MG per 10 ML Injection
Full name
eteplirsen 500 MG per 10 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Exondys 51ETEPLIRSENSarepta Therapeutics, Inc.33bff678-7829-479e-9110-b8e33a0bc0aa2025-08-13Warnings, Adverse reactionsExact identifier
rxcui: 1810581

Reported adverse events (FAERS/openFDA)#

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

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
33bff678-7829-479e-9110-b8e33a0bc0aaeteplirsen 500 MG in 10 ML Injection [PSN] · 10 ML eteplirsen 50 MG/ML Injection [SCD] · eteplirsen 500 MG per 10 ML Injection [SY]315These highlights do not include all the information needed to use EXONDYS 51 ® safely and effectively. See full prescribing information for EXONDYS 51. EXONDYS 51 (eteplirsen) injection, for intravenous use Initial U.S. Approval: 201620250813