FDA.reportPublic FDA data

68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection

RxCUI
2572002
RxNorm name
68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection
Display name
68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection
Full name
68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125703TecartusBrexucabtagene 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
TECARTUSBREXUCABTAGENE AUTOLEUCELKite Pharma, Inc.a16108c2-7ca7-45af-965e-54bda47130222026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2572002

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
a16108c2-7ca7-45af-965e-54bda4713022brexucabtagene autoleucel 100,000,000 CELLS per 68 ML Injection [PSN] · 68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection [SCD] · brexucabtagene autoleucel 100,000,000 CELLS per 68 ML Injection [SY]316These highlights do not include all the information needed to use TECARTUS safely and effectively. See full prescribing information for TECARTUS. TECARTUS ® (brexucabtagene autoleucel) suspension for intravenous infusion Initial U.S. Approval: 202020260401