FDA.reportPublic FDA data

AMTAGVI

Product NDC
73776-001
Requested package NDC
73776-001-12
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

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

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
application number: BLA125773
ndc (package): 73776-001-12
ndc (product): 73776-001
ndc11 (package): 73776000112

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
73776-001-12737760001121 BAG in 1 CARTRIDGE (73776-001-12) / 125 mL in 1 BAG (73776-001-11) 1 bag2024-02-16NoNoCurrent