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 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.
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
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 2026-06-01
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