FDA.reportPublic FDA data

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
BLAProprietary nameProper nameLicense typeStatusLatest source
125717Zynteglobetibeglogene autotemcel351(a)Rx2026-06-01

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#

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: 2610435

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
86931613-c262-47f5-8202-bc31fa69ad3dbetibeglogene autotemcel 20 ML InjectionPSN6These 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
86931613-c262-47f5-8202-bc31fa69ad3d20 ML betibeglogene autotemcel 20000000 CELLS/ML InjectionSCD6These 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
86931613-c262-47f5-8202-bc31fa69ad3dbetibeglogene autotemcel 20 ML InjectionSY6These 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