FDA.reportPublic FDA data

AMTAGVI

Product NDC
73776-001
11-digit product format
737760001
Labeler code
73776
Product ID
73776-001_4120d6b2-93d7-e0bf-e063-6294a90a6e7f
Type
CELLULAR THERAPY
Nonproprietary name
lifileucel
Dosage form
SUSPENSION
Route
INTRAVENOUS
Labeler
Iovance Biotherapeutics Inc.
Application
BLA125773
Marketing category
BLA
Marketing start
2024-02-16
Substance
LIFILEUCEL
Active strength
72000000000 1/500mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
application number: BLA125773
ndc (product): 73776-001

Additional Listing Data#

Finished product
Yes
Brand name base
AMTAGVI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIFILEUCEL72000000000 1/500mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R0835E18NHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2675868Internal RxNorm lookup
2675874Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4121bd3f-2d6e-3bdd-e063-6294a90a3088Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73776-001-11AMTAGVI125 mL in 1 BAGSUSPENSION1254
73776-001-12AMTAGVI1 in 1 CARTRIDGESUSPENSION14
73776-001-11AMTAGVI125 mL in 1 BAGSUSPENSION1253
73776-001-12AMTAGVI1 in 1 CARTRIDGESUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73776-001-11EA - Each73776-001a634d9ee-aa33-4558-95ba-ff9bce86693912024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73776-001AMTAGVI (LIFILEUCEL) SUSPENSION [IOVANCE BIOTHERAPEUTICS INC.]2Current NDC, 2 package rows20241023_91b0c63a-9a7e-46d0-a562-dc0d7d7867f3.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125773AMTAGVILifileucel351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675874AMTAGVI 72,000,000,000 CELLS in 125 ML InjectionPSN4121bd3f-2d6e-3bdd-e063-6294a90a30884
2675868lifileucel 72,000,000,000 CELLS in 125 ML InjectionPSN4121bd3f-2d6e-3bdd-e063-6294a90a30884
2675874125 ML lifileucel 576000000 CELLS/ML Injection [Amtagvi]SBD4121bd3f-2d6e-3bdd-e063-6294a90a30884
2675868125 ML lifileucel 576000000 CELLS/ML InjectionSCD4121bd3f-2d6e-3bdd-e063-6294a90a30884
2675874125 ML Amtagvi 576000000 CELLS/ML InjectionSY4121bd3f-2d6e-3bdd-e063-6294a90a30884
2675874Amtagvi 72,000,000,000 CELLS per 125 ML InjectionSY4121bd3f-2d6e-3bdd-e063-6294a90a30884
2675868lifileucel 72,000,000,000 CELLS per 125 ML InjectionSY4121bd3f-2d6e-3bdd-e063-6294a90a30884
2675874AMTAGVI 72,000,000,000 CELLS in 125 ML InjectionPSN91b0c63a-9a7e-46d0-a562-dc0d7d7867f33
2675868lifileucel 72,000,000,000 CELLS in 125 ML InjectionPSN91b0c63a-9a7e-46d0-a562-dc0d7d7867f33
2675874125 ML lifileucel 576000000 CELLS/ML Injection [Amtagvi]SBD91b0c63a-9a7e-46d0-a562-dc0d7d7867f33
2675868125 ML lifileucel 576000000 CELLS/ML InjectionSCD91b0c63a-9a7e-46d0-a562-dc0d7d7867f33
2675874125 ML Amtagvi 576000000 CELLS/ML InjectionSY91b0c63a-9a7e-46d0-a562-dc0d7d7867f33
2675874Amtagvi 72,000,000,000 CELLS per 125 ML InjectionSY91b0c63a-9a7e-46d0-a562-dc0d7d7867f33
2675868lifileucel 72,000,000,000 CELLS per 125 ML InjectionSY91b0c63a-9a7e-46d0-a562-dc0d7d7867f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73776-001-1173776000111125 mL in 1 BAG125 mlHistorical
73776-001-12737760001121 BAG in 1 CARTRIDGE (73776-001-12) / 125 mL in 1 BAG (73776-001-11) 1 bag2024-02-16NoNoCurrent