Home NDC 51144-003 TIVDAK
Product NDC 51144-003
11-digit product format 511440003
Labeler code 51144
Product ID 51144-003_62959a22-02f7-463c-80bb-3c5e621b1f58
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tisotumab vedotin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler SEAGEN INC.
Application BLA761208
Marketing category BLA
Marketing start 2021-09-20
Substance TISOTUMAB VEDOTIN
Active strength 40 mg/4mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base TIVDAK
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TISOTUMAB VEDOTIN 40 mg/4mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T41737F88A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2571099 Internal RxNorm lookup 2571104 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51144-003-01 TIVDAK 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 10 51144-003-01 TIVDAK 4 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 4 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51144-003 TIVDAK (TISOTUMAB VEDOTIN) INJECTION, POWDER, FOR SOLUTION [SEAGEN INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241105_c9fe3f32-4219-466e-acb9-3f609b4f4df1.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TIVDAK TISOTUMAB VEDOTIN SEAGEN INC. c9fe3f32-4219-466e-acb9-3f609b4f4df1 2025-11-20 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761208 ndc (product): 51144-003
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761208 Tivdak tisotumab vedotin-tftv 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51144-003-01 51144000301 1 VIAL in 1 CARTON (51144-003-01) / 4 mL in 1 VIAL 1 vial 2021-09-20 0000-00-00 No No Current