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  5. NDC Package Code: 73776-001-12 Amtagvi

NDC Package 73776-001-12 Amtagvi

Lifileucel Suspension Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Amtagvi
Non-Proprietary Name:
Lifileucel
Substance Name:
Lifileucel
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).
11-Digit NDC Billing Format:
73776000112
NDC to RxNorm Crosswalk:
  • RxCUI: 2675868 - lifileucel 72,000,000,000 CELLS in 125 ML Injection
  • RxCUI: 2675868 - 125 ML lifileucel 576000000 CELLS/ML Injection
  • RxCUI: 2675868 - lifileucel 72,000,000,000 CELLS per 125 ML Injection
  • RxCUI: 2675874 - AMTAGVI 72,000,000,000 CELLS in 125 ML Injection
  • RxCUI: 2675874 - 125 ML lifileucel 576000000 CELLS/ML Injection [Amtagvi]
    • Product Type:
    Cellular Therapy
    Labeler Name:
    Iovance Biotherapeutics Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • LIFILEUCEL 72000000000 1/500mL
    • Sample Package:
    No
    FDA Application Number:
    BLA125773
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-16-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 73776-001-12?

    The NDC Packaged Code 73776-001-12 is assigned to a 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.. The product's dosage form is suspension and is administered via intravenous form.

    Is NDC 73776-001 included in the NDC Directory?

    Yes, Amtagvi with product code 73776-001 is active and included in the NDC Directory. The product was first marketed by Iovance Biotherapeutics Inc. on February 16, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 73776-001-12?

    The 11-digit format is 73776000112. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-273776-001-125-4-273776-0001-12