FDA.reportPublic FDA data

lisocabtagene maraleucel 70,000,000 CELLS/ML per 4.6 ML Injection

RxCUI
2479140
RxNorm name
lisocabtagene maraleucel 70,000,000 CELLS/ML per 4.6 ML Injection
Display name
lisocabtagene maraleucel 70,000,000 CELLS/ML per 4.6 ML Injection
Full name
lisocabtagene maraleucel 70,000,000 CELLS/ML per 4.6 ML Injection
Term type
SY
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)Rx2026-06-01

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
BREYANZILISOCABTAGENE MARALEUCELJuno Therapeutics, Inc.594bb413-af3b-4b97-afb3-bfe2b174f2ed2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2479140

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
594bb413-af3b-4b97-afb3-bfe2b174f2edlisocabtagene maraleucel 70,000,000 CELLS/ML per 4.6 ML InjectionSY15These 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
594bb413-af3b-4b97-afb3-bfe2b174f2edlisocabtagene maraleucel 70,000,000 CELLS/mL in 4.6 mL InjectionPSN15These 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
594bb413-af3b-4b97-afb3-bfe2b174f2ed4.6 ML lisocabtagene maraleucel 70000000 CELLS/ML InjectionSCD15These 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