FDA.reportPublic FDA data

Exondys 51, 500 MG in 10 ML Injection

RxCUI
1810582
RxNorm name
Exondys 51, 500 MG in 10 ML Injection
Display name
Exondys 51, 500 MG in 10 ML Injection
Full name
Exondys 51, 500 MG in 10 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: 1810582

Reported adverse events (FAERS/openFDA)#

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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-b8e33a0bc0aaExondys 51, 500 MG in 10 ML Injection [PSN] · 10 ML eteplirsen 50 MG/ML Injection [Exondys] [SBD] · 10 ML Exondys 50 MG/ML Injection [SY] · Exondys 500 MG per 10 ML Injection [SY]415These 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