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
BLA	Proprietary name	Proper name	License type	Status	Latest source
125738	OMISIRGE	omidubicel-onlv	351(a)	Rx	2026-06-01

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OMISIRGE	OMIDUBICEL-ONLV	Gamida Cell Inc.	979803c9-956c-42e7-9d75-c37cc4e90632	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2637363

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
979803c9-956c-42e7-9d75-c37cc4e90632	omidubicel-onlv Cultured and Non-Cultured Injection Pack	SY	8	These 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: 2023	20260219
979803c9-956c-42e7-9d75-c37cc4e90632	omidubicel-onlv Cultured and Non-Cultured Injection Pack	PSN	8	These 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: 2023	20260219
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	8	These 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: 2023	20260219