FDA.reportPublic FDA data

omidubicel-onlv 400,000,000 CELLS per 50 ML Injection

RxCUI
2637362
RxNorm name
omidubicel-onlv 400,000,000 CELLS per 50 ML Injection
Display name
omidubicel-onlv 400,000,000 CELLS per 50 ML Injection
Full name
omidubicel-onlv 400,000,000 CELLS per 50 ML Injection
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: 2637362

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-c37cc4e90632omidubicel-onlv 400,000,000 CELLS in 50 ML Injection [PSN] · 50 ML omidubicel-onlv 8000000 CELLS/ML Injection [SCD] · omidubicel-onlv 400,000,000 CELLS per 50 ML Injection [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