Amtagvi Suspension
NDC Package 73776-001-12

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Amtagvi (lifileucel) suspension is aMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.This indication is approved under accelerated approval based on objective response rate (ORR) [see Clinical Studies (14)]. This formulation utilizes a suspension delivery system. Marketed by Iovance Biotherapeutics Inc., this product is identified by NDC 73776-001 and is authorized under FDA application BLA125773.

Identification & Billing

NDC Package Code
73776-001-12
Package Description
1 BAG in 1 CARTRIDGE / 125 mL in 1 BAG (73776-001-11)
Product Code
73776-001
11-Digit Billing Format
73776000112
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amtagvi
Non-Proprietary Name
Lifileucel
Substance Name
Lifileucel
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LIFILEUCEL 72000000000 1/500mL
Usage Information
AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.This indication is approved under accelerated approval based on objective response rate (ORR) [see Clinical Studies (14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Iovance Biotherapeutics Inc.
Product Type
Cellular Therapy
FDA Application #
BLA125773
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-16-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 73776-001-12 identifies a specific commercial package of 1 bag in 1 cartridge / 125 ml in 1 bag (73776-001-11) of Amtagvi, a cellular therapy labeled by Iovance Biotherapeutics Inc.. This suspension is formulated for intravenous use and contains lifileucel as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Iovance Biotherapeutics Inc. on February 16, 2024. The current certification is valid through December 31, 2026.

How is this Iovance Biotherapeutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73776000112. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
73776-001-12
11-Digit CMS (5-4-2)
73776-0001-12

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.