FDA.reportPublic FDA data

{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 10 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } Pack

RxCUI
2630773
RxNorm name
{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 10 (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) / 10 (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) / 10 (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)Rx2026-09-01

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
ZolgensmaONASEMNOGENE ABEPARVOVEC-XIOINovartis Innovative Technologies Inc.68cd4f06-70e1-40d8-bedb-609ec0afa4712026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2630773

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
68cd4f06-70e1-40d8-bedb-609ec0afa471{2 (5.5 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) / 10 (8.3 ML onasemnogene abeparvovec-xioi 20000000000000 VECTOR-GENOMES/ML Injection) } Pack [GPCK] · onasemnogene abeparvovec-xioi Kit Patient Weight 16.6 - 17.0 KG [PSN] · onasemnogene abeparvovec-xioi Kit Patient Weight 16.6 - 17.0 KG [SY]314These 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