FDA.reportPublic FDA data

tebentafusp-tebn 100 MCG in 0.5 ML Injection

RxCUI
2590748
RxNorm name
tebentafusp-tebn 100 MCG in 0.5 ML Injection
Display name
tebentafusp-tebn 100 MCG in 0.5 ML Injection
Full name
tebentafusp-tebn 100 MCG in 0.5 ML Injection
Term type
PSN
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)Rx2026-08-01

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#

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
rxcui: 2590748

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
24a49f57-d2fc-4ffe-9eb1-fe0460c6b067tebentafusp-tebn 100 MCG in 0.5 ML Injection [PSN] · 0.5 ML tebentafusp-tebn 0.2 MG/ML Injection [SCD] · tebentafusp-tebn 100 MCG per 0.5 ML Injection [SY]38These 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