FDA.reportPublic FDA data

tisotumab vedotin-tftv 40 MG Injection

RxCUI
2571099
RxNorm name
tisotumab vedotin-tftv 40 MG Injection
Display name
tisotumab vedotin-tftv 40 MG Injection
Full name
tisotumab vedotin-tftv 40 MG Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761208Tivdaktisotumab vedotin-tftv351(a)Rx2026-09-01

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
TIVDAKTISOTUMAB VEDOTINSEAGEN INC.c9fe3f32-4219-466e-acb9-3f609b4f4df12025-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2571099

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
c9fe3f32-4219-466e-acb9-3f609b4f4df1tisotumab vedotin-tftv 40 MG Injection [PSN] · tisotumab vedotin-tftv 40 MG Injection [SCD]210These highlights do not include all the information needed to use TIVDAK safely and effectively. See full prescribing information for TIVDAK. TIVDAK ® (tisotumab vedotin-tftv) for injection, for intravenous use Initial U.S. Approval: 202120251120