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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a16108c2-7ca7-45af-965e-54bda471302268 ML brexucabtagene autoleucel 1471000 CELLS/ML InjectionSCD16These 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
a16108c2-7ca7-45af-965e-54bda4713022brexucabtagene autoleucel 100,000,000 CELLS per 68 ML InjectionSY16These 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
a16108c2-7ca7-45af-965e-54bda4713022brexucabtagene autoleucel 100,000,000 CELLS per 68 ML InjectionPSN16These 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