FDA.reportPublic FDA data

20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]

RxCUI
2610436
RxNorm name
20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]
Display name
20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]
Full name
20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125717Zynteglobetibeglogene autotemcel351(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
ZyntegloBETIBEGLOGENE AUTOTEMCELGenetix Biotherapeutics Inc.86931613-c262-47f5-8202-bc31fa69ad3d2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 2610436

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
86931613-c262-47f5-8202-bc31fa69ad3dzynteglo 20 ML Injection [PSN] · 20 ML betibeglogene autotemcel 20000000 CELLS/ML Injection [Zynteglo] [SBD] · 20 ML Zynteglo 20000000 CELLS/ML Injection [SY]36These 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: 202220260407