FDA.reportPublic FDA data

KIMMTRAK

Product NDC
80446-401
11-digit product format
804460401
Labeler code
80446
Product ID
80446-401_dac2462e-31fb-4725-9f75-2ebdde41ab96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TEBENTAFUSP
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Immunocore Commercial LLC
Application
BLA761228
Marketing category
BLA
Marketing start
2022-01-26
Substance
TEBENTAFUSP
Active strength
100 ug/.5mL
Pharmacologic classes
Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager [EPC], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KIMMTRAK
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEBENTAFUSP100 ug/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN658GY6L3E
Rxcui2590748, 2590754

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80446-401-012024-03-06C16284748780-11030e365-5994-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use KIMMTRAK ® safely and effectively. See full prescribing information for KIMMTRAK ® . KIMMTRAK ® (tebentafusp-tebn) injection, for intravenous use Initial U.S. Approval: 2022
80446-401-012024-01-30C16284748780-11030e365-5994-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use KIMMTRAK ® safely and effectively. See full prescribing information for KIMMTRAK ® . KIMMTRAK ® (tebentafusp-tebn) injection, for intravenous use Initial U.S. Approval: 2022

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80446-401-01KIMMTRAK1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE18
80446-401-01KIMMTRAK.5 mL in 1 VIAL, GLASSINJECTION, SOLUTION, CONCENTRATE.58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80446-401KIMMTRAK (TEBENTAFUSP) INJECTION, SOLUTION, CONCENTRATE [IMMUNOCORE COMMERCIAL LLC]8Current NDC, Legacy NDC, 2 package rows20250508_24a49f57-d2fc-4ffe-9eb1-fe0460c6b067.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2590754KIMMTRAK 100 MCG in 0.5 ML InjectionPSN24a49f57-d2fc-4ffe-9eb1-fe0460c6b0678
2590748tebentafusp-tebn 100 MCG in 0.5 ML InjectionPSN24a49f57-d2fc-4ffe-9eb1-fe0460c6b0678
25907540.5 ML tebentafusp-tebn 0.2 MG/ML Injection [Kimmtrak]SBD24a49f57-d2fc-4ffe-9eb1-fe0460c6b0678
25907480.5 ML tebentafusp-tebn 0.2 MG/ML InjectionSCD24a49f57-d2fc-4ffe-9eb1-fe0460c6b0678
25907540.5 ML Kimmtrak 0.2 MG/ML InjectionSY24a49f57-d2fc-4ffe-9eb1-fe0460c6b0678
2590754Kimmtrak 100 MCG per 0.5 ML InjectionSY24a49f57-d2fc-4ffe-9eb1-fe0460c6b0678
2590748tebentafusp-tebn 100 MCG per 0.5 ML InjectionSY24a49f57-d2fc-4ffe-9eb1-fe0460c6b0678

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80446-401-01804460401011 VIAL, GLASS in 1 CARTON (80446-401-01) / .5 mL in 1 VIAL, GLASS2022-01-260000-00-00NoNoCurrent