FDA.reportPublic FDA data

delandistrogene moxeparvovec-rokl Kit Patient Weight 20.5 - 21.4 KG

RxCUI
2641709
RxNorm name
delandistrogene moxeparvovec-rokl Kit Patient Weight 20.5 - 21.4 KG
Display name
delandistrogene moxeparvovec-rokl Kit Patient Weight 20.5 - 21.4 KG
Full name
delandistrogene moxeparvovec-rokl Kit Patient Weight 20.5 - 21.4 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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-cffdf2e8a3612025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2641709

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3525abcd-fbd2-46c5-9706-cffdf2e8a361delandistrogene moxeparvovec-rokl Kit Patient Weight 20.5 - 21.4 KGPSN11These 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
3525abcd-fbd2-46c5-9706-cffdf2e8a361delandistrogene moxeparvovec-rokl Kit Patient Weight 20.5 - 21.4 KGSY11These 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
3525abcd-fbd2-46c5-9706-cffdf2e8a361{21 (10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection) } PackGPCK11These 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