FDA.reportPublic FDA data

2 ML Exondys 50 MG/ML Injection

RxCUI
1810578
RxNorm name
2 ML Exondys 50 MG/ML Injection
Display name
2 ML Exondys 50 MG/ML Injection
Full name
2 ML Exondys 50 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

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: 1810578

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-b8e33a0bc0aaExondys 51, 100 MG in 2 ML Injection [PSN] · 2 ML eteplirsen 50 MG/ML Injection [Exondys] [SBD] · 2 ML Exondys 50 MG/ML Injection [SY] · Exondys 100 MG per 2 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