Kimmtrak Injection, Solution, Concentrate
NDC Package 80446-401-01

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

Package Information

Kimmtrak (tebentafusp) injection is kIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Immunocore Commercial Llc, this product is identified by NDC 80446-401 and is authorized under FDA application BLA761228.

Identification & Billing

NDC Package Code
80446-401-01
Package Description
1 VIAL, GLASS in 1 CARTON / .5 mL in 1 VIAL, GLASS
Product Code
80446-401
11-Digit Billing Format
80446040101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kimmtrak
Non-Proprietary Name
Tebentafusp
Substance Name
Tebentafusp
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TEBENTAFUSP 100 ug/.5mL
Pharmacologic Class
Usage Information
KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Regulatory & Marketing

Labeler Name
Immunocore Commercial Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761228
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-26-2022
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9274
Source: ASP
Inj, tebentafusp-tebn, 1 mcg
HCPCS Dosage 1 MCG
Units / Pkg 100

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 80446-401-01 identifies a specific commercial 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. This injection, solution, concentrate is formulated for intravenous use and contains tebentafusp 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 Immunocore Commercial Llc on January 26, 2022. The current certification is valid through December 31, 2026.

How is this Immunocore Commercial Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80446040101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
80446-401-01
11-Digit CMS (5-4-2)
80446-0401-01

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