FDA.reportPublic FDA data

ELEVIDYS 13300000000000 VECTOR-GENOMES in 10 ML Injection

RxCUI
2641685
RxNorm name
ELEVIDYS 13300000000000 VECTOR-GENOMES in 10 ML Injection
Display name
ELEVIDYS 13300000000000 VECTOR-GENOMES in 10 ML Injection
Full name
ELEVIDYS 13300000000000 VECTOR-GENOMES in 10 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125781ELEVIDYSdelandistrogene moxeparvovec-rokl351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELEVIDYSDELANDISTROGENE MOXEPARVOVEC-ROKLSarepta Therapeutics, Inc.3525abcd-fbd2-46c5-9706-cffdf2e8a3612026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2641685

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
3525abcd-fbd2-46c5-9706-cffdf2e8a361ELEVIDYS 13300000000000 VECTOR-GENOMES in 10 ML Injection [PSN] · 10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection [Elevidys] [SBD] · Elevidys 13300000000000 VECTOR-GENOMES per 10 ML Injection [SY]311These highlights do not include all the information needed to use ELEVIDYS ® safely and effectively. See full prescribing information for ELEVIDYS. ELEVIDYS (delandistrogene moxeparvovec-rokl) suspension, for intravenous infusion Initial U.S. Approval: 202320251121