What is NDC 80446-401?

80446-401 is the product NDC for Kimmtrak (tebentafusp), Tebentafusp 100 ug/.5mL injection, solution, concentrate, listed with the FDA by Immunocore Commercial LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Immunocore Commercial LLC, NDC labeler code 80446. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Kimmtrak?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Kimmtrak NDC 80446-401 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80446-401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80446-0401Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
80446-401-01	80446040101	1 VIAL, GLASS in 1 CARTON (80446-401-01) / .5 mL in 1 VIAL, GLASSMarketed from Jan 26, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Kimmtrak
Generic name (nonproprietary): tebentafusp
Active ingredients: Tebentafusp — 100 ug/.5mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Immunocore Commercial LLCNDC labeler code 80446
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761228
Marketing start: Jan 26, 2022
Listing expires: Dec 31, 2027
Other FDA classes: CD3 Receptor Agonists (Mechanism)CD3-directed Antibody Interactions (Mechanism)Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 80446-401_6da26ba2-92a2-4c0f-b733-946f25c71338SPL ID 6da26ba2-92a2-4c0f-b733-946f25c71338SPL set ID 24a49f57-d2fc-4ffe-9eb1-fe0460c6b067RxCUI 2590748, 2590754UNII N658GY6L3EUPC 0380446401013
Pharmacologic class: Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N480446040101 followed by a unit qualifier and the quantity

Package 80446-0401-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Aug 20, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80446-401

What is NDC 80446-401?: 80446-401 is the product NDC for Kimmtrak (tebentafusp), Tebentafusp 100 ug/.5mL injection, solution, concentrate, listed with the FDA by Immunocore Commercial LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Kimmtrak (Tebentafusp).
What is the active ingredient?: Tebentafusp.
Who is the labeler?: Immunocore Commercial LLC, NDC labeler code 80446. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Kimmtrak?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Kimmtrak (Tebentafusp) NDC 80446-401