FDA.reportPublic FDA data

2 ML golodirsen 50 MG/ML Injection [Vyondys 53]

RxCUI
2267216
RxNorm name
2 ML golodirsen 50 MG/ML Injection [Vyondys 53]
Display name
2 ML golodirsen 50 MG/ML Injection [Vyondys 53]
Full name
2 ML golodirsen 50 MG/ML Injection [Vyondys 53]
Term type
SBD
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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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vyondys 53GOLODIRSENSarepta Therapeutics, Inc.35c227d1-5b24-44b0-b5d3-f0f6b1c46bd52025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 2267216

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
35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5VYONDYS 53 Injection 100 MG in 2 ML [PSN] · 2 ML golodirsen 50 MG/ML Injection [Vyondys 53] [SBD] · 2 ML Vyondys 53 50 MG/ML Injection [SY] · VYONDYS 53 Injection 100 MG per 2 ML [SY]416These highlights do not include all the information needed to use VYONDYS 53 safely and effectively. See full prescribing information for VYONDYS 53. VYONDYS 53 (golodirsen) injection, for intravenous use Initial U.S. Approval: 201920250313