FDA.reportPublic FDA data

obecabtagene autoleucel Kit 3-5 Bag

RxCUI
2700174
RxNorm name
obecabtagene autoleucel Kit 3-5 Bag
Display name
obecabtagene autoleucel Kit 3-5 Bag
Full name
obecabtagene autoleucel Kit 3-5 Bag
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:58

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125813AucatzylObecabtagene autoleucel351(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
AUCATZYLOBECABTAGENE AUTOLEUCELAutolus Inc.4fef6986-b988-45e4-8c20-b14f0ef1f5382026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2700174

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
4fef6986-b988-45e4-8c20-b14f0ef1f538{5 (obecabtagene autoleucel 410000000 CELLS/ML Injection) } Pack [GPCK] · obecabtagene autoleucel Kit 3-5 Bag [PSN] · obecabtagene autoleucel Kit 3-5 Bag [SY]35These highlights do not include all the information needed to use AUCATZYL safely and effectively. See full prescribing information for AUCATZYL. AUCATZYL ® (obecabtagene autoleucel) suspension for intravenous infusion Initial U.S. Approval: 202420260227