betibeglogene autotemcel 20 ML Injection

RxCUI: 2610435
RxNorm name: betibeglogene autotemcel 20 ML Injection
Display name: betibeglogene autotemcel 20 ML Injection
Full name: betibeglogene autotemcel 20 ML Injection
Term type: PSN
Status: DailyMed mapping
Updated: 2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125717	Zynteglo	betibeglogene autotemcel	351(a)	Rx	2026-09-01

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zynteglo	BETIBEGLOGENE AUTOTEMCEL	Genetix Biotherapeutics Inc.	86931613-c262-47f5-8202-bc31fa69ad3d	2026-07-21	Warnings, Adverse reactions	Exact identifier rxcui: 2610435

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
86931613-c262-47f5-8202-bc31fa69ad3d	betibeglogene autotemcel 20 ML Injection [PSN] · 20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [SCD] · betibeglogene autotemcel 20 ML Injection [SY]	3	6	These highlights do not include all the information needed to use ZYNTEGLO ® safely and effectively. See full prescribing information for ZYNTEGLO. ZYNTEGLO (betibeglogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 2022	20260407