FDA.reportPublic FDA data

delandistrogene moxeparvovec-rok Kit Patient Weight 18.5 - 19.4 KG

RxCUI
2641705
RxNorm name
delandistrogene moxeparvovec-rok Kit Patient Weight 18.5 - 19.4 KG
Display name
delandistrogene moxeparvovec-rok Kit Patient Weight 18.5 - 19.4 KG
Full name
delandistrogene moxeparvovec-rok Kit Patient Weight 18.5 - 19.4 KG
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: 2641705

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-cffdf2e8a361{19 (10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection) } Pack [GPCK] · delandistrogene moxeparvovec-rok Kit Patient Weight 18.5 - 19.4 KG [PSN] · delandistrogene moxeparvovec-rok Kit Patient Weight 18.5 - 19.4 KG [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