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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEBENTAFUSP100 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N658GY6L3EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2590748Internal RxNorm lookup
2590754Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
24a49f57-d2fc-4ffe-9eb1-fe0460c6b067Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-03-06These 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
2024-03-06These 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
2024-01-30These 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
2024-01-30These 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80446-401-01ML - Milliliter80446-4017959829e-7c2a-4662-b623-7894e2092ca812022-02-07

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KIMMTRAKTEBENTAFUSPImmunocore Commercial LLC24a49f57-d2fc-4ffe-9eb1-fe0460c6b0672026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761228
ndc (product): 80446-401

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761228Kimmtraktebentafusp-tebn351(a)Rx2026-08-01

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