Home NDC 72579-121 TEVIMBRA
Product NDC 72579-121
11-digit product format 725790121
Labeler code 72579
Product ID 72579-121_bc267296-25e7-42ee-a4d7-19b64f9fd279
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tislelizumab-jsgr
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler BeOne Medicines USA, Inc.
Application BLA761232
Marketing category BLA
Marketing start 2024-03-14
Substance TISLELIZUMAB
Active strength 10 mg/mL
Pharmacologic classes Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base TEVIMBRA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TISLELIZUMAB 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0KVO411B3N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2677432 Internal RxNorm lookup 2677439 Internal RxNorm lookup 2747128 Internal RxNorm lookup 2747129 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 72579-121-01 TEVIMBRA 10 mL in 1 VIAL, GLASS INJECTION, SOLUTION, CONCENTRATE 10 12 72579-121-01 TEVIMBRA 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72579-121 TEVIMBRA (TISLELIZUMAB-JSGR) INJECTION, SOLUTION, CONCENTRATE [BEONE MEDICINES USA, INC.] 6 Current NDC, 2 package rows 20250514_08ef1e3e-496f-4b0b-94ee-fbba3cc1985a.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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761232 Tevimbra tislelizumab-jsgr 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72579-121-01 72579012101 1 VIAL, GLASS in 1 CARTON (72579-121-01) / 10 mL in 1 VIAL, GLASS 2024-03-14 No No Current