FDA.reportPublic FDA data

eteplirsen 100 MG in 2 ML Injection

RxCUI
1810573
RxNorm name
eteplirsen 100 MG in 2 ML Injection
Display name
eteplirsen 100 MG in 2 ML Injection
Full name
eteplirsen 100 MG in 2 ML Injection
Term type
PSN
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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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: 1810573

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 100 MG in 2 ML Injection [PSN] · 2 ML eteplirsen 50 MG/ML Injection [SCD] · eteplirsen 100 MG per 2 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