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  5. NDC Package Code: 80446-401-01 Kimmtrak

NDC Package 80446-401-01 Kimmtrak

Tebentafusp Injection, Solution, Concentrate Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
80446-401-01
Package Description:
1 VIAL, GLASS in 1 CARTON / .5 mL in 1 VIAL, GLASS
Product Code:
80446-401
Proprietary Name:
Kimmtrak
Non-Proprietary Name:
Tebentafusp
Substance Name:
Tebentafusp
Usage Information:
KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
11-Digit NDC Billing Format:
80446040101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2590748 - tebentafusp-tebn 100 MCG in 0.5 ML Injection
  • RxCUI: 2590748 - 0.5 ML tebentafusp-tebn 0.2 MG/ML Injection
  • RxCUI: 2590748 - tebentafusp-tebn 100 MCG per 0.5 ML Injection
  • RxCUI: 2590754 - KIMMTRAK 100 MCG in 0.5 ML Injection
  • RxCUI: 2590754 - 0.5 ML tebentafusp-tebn 0.2 MG/ML Injection [Kimmtrak]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Immunocore Commercial Llc
    Dosage Form:
    Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TEBENTAFUSP 100 ug/.5mL
    • Pharmacologic Class(es):
  • Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager - [EPC] (Established Pharmacologic Class)
  • CD3 Receptor Agonists - [MoA] (Mechanism of Action)
  • CD3-directed Antibody Interactions - [MoA] (Mechanism of Action)
  • Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA761228
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    01-26-2022
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 80446-401-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    80446040101J9274Inj, tebentafusp-tebn, 1 mcg1 MCG0.51100100

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 80446-401-01?

    The NDC Packaged Code 80446-401-01 is assigned to a package of 1 vial, glass in 1 carton / .5 ml in 1 vial, glass of Kimmtrak, a human prescription drug labeled by Immunocore Commercial Llc. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

    Is NDC 80446-401 included in the NDC Directory?

    Yes, Kimmtrak with product code 80446-401 is active and included in the NDC Directory. The product was first marketed by Immunocore Commercial Llc on January 26, 2022 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 NDC billing unit for package 80446-401-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 80446-401-01?

    The 11-digit format is 80446040101. 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
    5-3-280446-401-015-4-280446-0401-01