FDA.reportPublic FDA data

Breyanzi 70,000,000 CELLS/mL in 4.6 mL Injection

RxCUI
2479145
RxNorm name
Breyanzi 70,000,000 CELLS/mL in 4.6 mL Injection
Display name
Breyanzi 70,000,000 CELLS/mL in 4.6 mL Injection
Full name
Breyanzi 70,000,000 CELLS/mL in 4.6 mL Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125714Breyanzilisocabtagene maraleucel351(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
BREYANZILISOCABTAGENE MARALEUCELJuno Therapeutics, Inc.594bb413-af3b-4b97-afb3-bfe2b174f2ed2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2479145

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
594bb413-af3b-4b97-afb3-bfe2b174f2edBreyanzi 70,000,000 CELLS/mL in 4.6 mL Injection [PSN] · 4.6 ML lisocabtagene maraleucel 70000000 CELLS/ML Injection [Breyanzi] [SBD] · 4.6 ML Breyanzi 70,000,000 CELLS/ML Injection [SY] · Breyanzi 70,000,000 CELLS/ML per 4.6 ML Injection [SY]415These highlights do not include all the information needed to use BREYANZI safely and effectively. See full prescribing information for BREYANZI. BREYANZI ® (lisocabtagene maraleucel) suspension for intravenous infusion Initial U.S. Approval: 202120260220