FDA.reportPublic FDA data

0.5 ML tebentafusp-tebn 0.2 MG/ML Injection [Kimmtrak]

RxCUI
2590754
RxNorm name
0.5 ML tebentafusp-tebn 0.2 MG/ML Injection [Kimmtrak]
Display name
0.5 ML tebentafusp-tebn 0.2 MG/ML Injection [Kimmtrak]
Full name
0.5 ML tebentafusp-tebn 0.2 MG/ML Injection [Kimmtrak]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761228Kimmtraktebentafusp-tebn351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-fe0460c6b0672025-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2590754

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
24a49f57-d2fc-4ffe-9eb1-fe0460c6b0670.5 ML tebentafusp-tebn 0.2 MG/ML Injection [Kimmtrak]SBD8These 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: 202220250506
24a49f57-d2fc-4ffe-9eb1-fe0460c6b0670.5 ML Kimmtrak 0.2 MG/ML InjectionSY8These 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: 202220250506
24a49f57-d2fc-4ffe-9eb1-fe0460c6b067KIMMTRAK 100 MCG in 0.5 ML InjectionPSN8These 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: 202220250506
24a49f57-d2fc-4ffe-9eb1-fe0460c6b067Kimmtrak 100 MCG per 0.5 ML InjectionSY8These 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: 202220250506