FDA.reportPublic FDA data

{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } Pack

RxCUI
2630779
RxNorm name
{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } Pack
Display name
{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } Pack
Full name
{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } Pack
Term type
GPCK
Status
DailyMed mapping
Updated
2026-06-04 23:39:02

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125694Zolgensmaonasemnogene abeparvovec-xioi351(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
ZolgensmaONASEMNOGENE ABEPARVOVEC-XIOINovartis Innovative Technologies Inc.68cd4f06-70e1-40d8-bedb-609ec0afa4712026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2630779

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
68cd4f06-70e1-40d8-bedb-609ec0afa471{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 11 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK14These highlights do not include all the information needed to use ZOLGENSMA safely and effectively. See full prescribing information for ZOLGENSMA. ZOLGENSMA ® (onasemnogene abeparvovec-xioi) suspension, for intravenous infusion Initial U.S. Approval: 201920251218
68cd4f06-70e1-40d8-bedb-609ec0afa471onasemnogene abeparvovec-xioi Kit Patient Weight 18.1 - 18.5 KGPSN14These highlights do not include all the information needed to use ZOLGENSMA safely and effectively. See full prescribing information for ZOLGENSMA. ZOLGENSMA ® (onasemnogene abeparvovec-xioi) suspension, for intravenous infusion Initial U.S. Approval: 201920251218
68cd4f06-70e1-40d8-bedb-609ec0afa471onasemnogene abeparvovec-xioi Kit Patient Weight 18.1 - 18.5 KGSY14These highlights do not include all the information needed to use ZOLGENSMA safely and effectively. See full prescribing information for ZOLGENSMA. ZOLGENSMA ® (onasemnogene abeparvovec-xioi) suspension, for intravenous infusion Initial U.S. Approval: 201920251218