FDA.reportPublic FDA data

{61 (10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection [Elevidys]) } Pack [Elevidys Kit 60.5 - 61.4 KG]

RxCUI
2641831
RxNorm name
{61 (10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection [Elevidys]) } Pack [Elevidys Kit 60.5 - 61.4 KG]
Display name
{61 (10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection [Elevidys]) } Pack [Elevidys Kit 60.5 - 61.4 KG]
Full name
{61 (10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection [Elevidys]) } Pack [Elevidys Kit 60.5 - 61.4 KG]
Term type
BPCK
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: 2641831

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3525abcd-fbd2-46c5-9706-cffdf2e8a361{61 (10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection [Elevidys]) } Pack [Elevidys Kit 60.5 - 61.4 KG]BPCK11These 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-cffdf2e8a361ELEVIDYS Kit Patient Weight 60.5 - 61.4 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-cffdf2e8a361Elevidys Kit Patient Weight 60.5 - 61.4 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