FDA.reportPublic FDA data

NDC 73776-001-11 - AMTAGVI

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
73776-001
Requested NDC
73776-001-11
Package NDCs from labels
73776-001-11, 73776-001-12
Manufacturer
Iovance Biotherapeutics Inc. | Advanced Therapies, LLC. | Iovance Biotherpeutics Manufacturing, LLC
Effective date
2025-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMTAGVI - Iovance Biotherapeutics Inc. | Advanced Therapies, LLC. | Iovance Biotherpeutics Manufacturing, LLCIovance Biotherapeutics Inc. | Advanced Therapies, LLC. | Iovance Biotherpeutics Manufacturing, LLC2025-10-14CELLULAR THERAPY
AMTAGVIIovance Biotherapeutics Inc. | Iovance Biotherpeutics Manufacturing, LLC | Advanced Therapies, LLC.2025-09-19CELLULAR THERAPY

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 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

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

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 ยท 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dimethyl SulfoxideDIMETHYL SULFOXIDERenova Pharmaceuticals LLC8f699de6-9d09-48da-9d95-4001d70085872026-07-20Warnings, Adverse reactionsExact identifier
unii: YOW8V9698H
GUNA-VIRUSALDESLEUKIN - EVERLASTING EXTRACT - FOMITOPSIS PINICOLA FRUITING BODY - INTERFERON GAMMA-1B - MELATONIN - METENKEFALIN - REISHI - SEROTONIN - SOYBEAN - SUS SCROFA BLOOD - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA SPLEEN -Guna spa53e741c4-8897-71f3-e063-6394a90a751d2026-07-01WarningsExact identifier
unii: M89N0Q7EQR
GUNA-PROSTATEALDESLEUKIN - BARIUM CARBONATE - CHASTE TREE - CHIMAPHILA UMBELLATA - CLEMATIS VITALBA - CONIUM MACULATUM FLOWERING TOP - DELPHINIUM STAPHISAGRIA SEED - DIGITALIS - FERRIC PICRATE - HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - MELATONIN - SAW PALMETTO - SELENIUM - SUS SCROFA PROSTATE - THUJA OCCIDENTALIS TWIG - TRANSFORMING GROWTH FACTOR BETA-1 - ZINC -Guna spab99bb9ea-339c-4476-8e3c-e1fcbcfd5cda2026-06-11WarningsExact identifier
unii: M89N0Q7EQR
AMTAGVILIFILEUCELIovance Biotherapeutics Inc.4121bd3f-2d6e-3bdd-e063-6294a90a30882025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125773
ndc (package): 73776-001-12
ndc (package): 73776-001-11
ndc (product): 73776-001
ndc11 (package): 73776000111
rxcui: 2675868
rxcui: 2675874
spl id: 4120d6b2-93d7-e0bf-e063-6294a90a6e7f
spl set id: 4121bd3f-2d6e-3bdd-e063-6294a90a3088
unii: R0835E18NH
9553e0b3-c5cd-4be0-aae5-1a8db162bf5391b0c63a-9a7e-46d0-a562-dc0d7d7867f32025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 9553e0b3-c5cd-4be0-aae5-1a8db162bf53
spl set id: 91b0c63a-9a7e-46d0-a562-dc0d7d7867f3
CITOMIXALDESLEUKIN - BINETRAKIN - CANAKINUMAB - CENTELLA ASIATICA - CRANBERRY - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - LENOGRASTIM - PINEAPPLE - SUS SCROFA BONE MARROW - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA THYMUS -Guna spa23886c49-5992-4a59-af52-e24eb3c9fbc52025-01-10WarningsExact identifier
unii: M89N0Q7EQR
PROLEUKINALDESLEUKINIovance Biotherapeutics, Incf3c516ad-d405-4fbe-af6a-962080dbfa7d2024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: M89N0Q7EQR
GUNA-IL 2ALDESLEUKINGuna spa0619f291-207a-4e01-96bd-b882726665e22022-11-15WarningsExact identifier
unii: M89N0Q7EQR
GUNA-VIRUSALDESLEUKIN - EVERLASTING EXTRACT - FOMITOPSIS PINICOLA FRUITING BODY - INTERFERON GAMMA-1B - MELATONIN - METENKEFALIN - REISHI - RICE - SEROTONIN - SOYBEAN - SUS SCROFA BLOOD - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA SPLEEN -Guna spa4a5714f9-e0ab-41b2-b214-fed33c8073582022-11-14WarningsExact identifier
unii: M89N0Q7EQR
RIMSO-50DIMETHYL SULFOXIDEMylan Institutional LLC58b25d79-78f2-4953-b0c6-61658dc4ef0d2021-03-17Warnings, Adverse reactionsExact identifier
unii: YOW8V9698H
GUNA-DERMOALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR -Guna spa8bf717eb-fe46-4066-b124-eb715ffc15422018-12-21WarningsExact identifier
unii: M89N0Q7EQR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.