FDA.reportPublic FDA data

omidubicel-onlv Cultured and Non-Cultured Injection Pack

RxCUI
2637363
RxNorm name
omidubicel-onlv Cultured and Non-Cultured Injection Pack
Display name
omidubicel-onlv Cultured and Non-Cultured Injection Pack
Full name
omidubicel-onlv Cultured and Non-Cultured Injection Pack
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:09

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125738OMISIRGEomidubicel-onlv351(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
OMISIRGEOMIDUBICEL-ONLVGamida Cell Inc.979803c9-956c-42e7-9d75-c37cc4e906322026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2637363

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
979803c9-956c-42e7-9d75-c37cc4e90632{1 (100 ML omidubicel-onlv 8000000 CELLS/ML Injection) / 1 (50 ML omidubicel-onlv 8000000 CELLS/ML Injection) } Pack [GPCK] · omidubicel-onlv Cultured and Non-Cultured Injection Pack [PSN] · omidubicel-onlv Cultured and Non-Cultured Injection Pack [SY]38These highlights do not include all the information needed to use OMISIRGE safely and effectively. See full prescribing information for OMISIRGE. OMISIRGE ® (omidubicel-onlv) Suspension for Intravenous Use Initial U.S. Approval: 202320260219