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)Rx2026-09-01

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
AMTAGVILIFILEUCELIovance Biotherapeutics Inc.4121bd3f-2d6e-3bdd-e063-6294a90a30882025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2675868

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4121bd3f-2d6e-3bdd-e063-6294a90a3088lifileucel 72,000,000,000 CELLS in 125 ML Injection [PSN] · 125 ML lifileucel 576000000 CELLS/ML Injection [SCD] · lifileucel 72,000,000,000 CELLS per 125 ML Injection [SY]34These 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 Injection [PSN] · 125 ML lifileucel 576000000 CELLS/ML Injection [SCD] · lifileucel 72,000,000,000 CELLS per 125 ML Injection [SY]33These 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