FDA.reportPublic FDA data

lifileucel 72,000,000,000 CELLS per 125 ML Injection

RxCUI
2675868
RxNorm name
lifileucel 72,000,000,000 CELLS per 125 ML Injection
Display name
lifileucel 72,000,000,000 CELLS per 125 ML Injection
Full name
lifileucel 72,000,000,000 CELLS per 125 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125773AMTAGVILifileucel351(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
AMTAGVILIFILEUCELIovance Biotherapeutics Inc.4121bd3f-2d6e-3bdd-e063-6294a90a30882025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2675868

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4121bd3f-2d6e-3bdd-e063-6294a90a3088lifileucel 72,000,000,000 CELLS per 125 ML InjectionSY4These highlights do not include all the information needed to use AMTAGVI safely and effectively. See full prescribing information for AMTAGVI. AMTAGVI (lifileucel) suspension for intravenous infusion Initial U.S. Approval: 202420251014
4121bd3f-2d6e-3bdd-e063-6294a90a3088lifileucel 72,000,000,000 CELLS in 125 ML InjectionPSN4These highlights do not include all the information needed to use AMTAGVI safely and effectively. See full prescribing information for AMTAGVI. AMTAGVI (lifileucel) suspension for intravenous infusion Initial U.S. Approval: 202420251014
4121bd3f-2d6e-3bdd-e063-6294a90a3088125 ML lifileucel 576000000 CELLS/ML InjectionSCD4These highlights do not include all the information needed to use AMTAGVI safely and effectively. See full prescribing information for AMTAGVI. AMTAGVI (lifileucel) suspension for intravenous infusion Initial U.S. Approval: 202420251014
91b0c63a-9a7e-46d0-a562-dc0d7d7867f3lifileucel 72,000,000,000 CELLS in 125 ML InjectionPSN3These highlights do not include all the information needed to use AMTAGVI safely and effectively. See full prescribing information for AMTAGVI. AMTAGVI (lifileucel) suspension for intravenous infusion Initial U.S. Approval: 202420250919
91b0c63a-9a7e-46d0-a562-dc0d7d7867f3lifileucel 72,000,000,000 CELLS per 125 ML InjectionSY3These highlights do not include all the information needed to use AMTAGVI safely and effectively. See full prescribing information for AMTAGVI. AMTAGVI (lifileucel) suspension for intravenous infusion Initial U.S. Approval: 202420250919
91b0c63a-9a7e-46d0-a562-dc0d7d7867f3125 ML lifileucel 576000000 CELLS/ML InjectionSCD3These highlights do not include all the information needed to use AMTAGVI safely and effectively. See full prescribing information for AMTAGVI. AMTAGVI (lifileucel) suspension for intravenous infusion Initial U.S. Approval: 202420250919