FDA.reportPublic FDA data

TEVIMBRA

Product NDC
72579-125
11-digit product format
725790125
Labeler code
72579
Product ID
72579-125_ff90fdd7-1cba-4a1d-8430-c5f071a1e440
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
2026-07-13
Substance
TISLELIZUMAB
Active strength
10 mg/mL
Pharmacologic classes
Programmed Death Receptor-1 Blocking Antibody [EPC]; Programmed Death Receptor-1-directed Antibody Interactions [MoA]
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
IngredientStrength
TISLELIZUMAB10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0KVO411B3NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2677432Internal RxNorm lookup
2677439Internal RxNorm lookup
2747128Internal RxNorm lookup
2747129Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08ef1e3e-496f-4b0b-94ee-fbba3cc1985aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c17a59c-7e5f-4962-9bd9-f8862385434cProduct name120250124
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

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
TEVIMBRATISLELIZUMAB-JSGRBeOne Medicines USA, Inc.08ef1e3e-496f-4b0b-94ee-fbba3cc1985a2026-05-22Warnings, Adverse reactionsExact identifier
application number: BLA761232
ndc (product): 72579-125

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761232Tevimbratislelizumab-jsgr351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677439TEVIMBRA 100 MG in 10 ML InjectionPSN08ef1e3e-496f-4b0b-94ee-fbba3cc1985a12
2677432tislelizumab-jsgr 100 MG in 10 ML InjectionPSN08ef1e3e-496f-4b0b-94ee-fbba3cc1985a12
267743910 ML tislelizumab-jsgr 10 MG/ML Injection [Tevimbra]SBD08ef1e3e-496f-4b0b-94ee-fbba3cc1985a12
267743210 ML tislelizumab-jsgr 10 MG/ML InjectionSCD08ef1e3e-496f-4b0b-94ee-fbba3cc1985a12
267743910 ML Tevimbra 10 MG/ML InjectionSY08ef1e3e-496f-4b0b-94ee-fbba3cc1985a12
2677439Tevimbra 100 MG per 10 ML InjectionSY08ef1e3e-496f-4b0b-94ee-fbba3cc1985a12
2677432tislelizumab-jsgr 100 MG per 10 ML InjectionSY08ef1e3e-496f-4b0b-94ee-fbba3cc1985a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleStatus
72579-125-00725790125001 VIAL, GLASS in 1 CARTON (72579-125-00) / 15 mL in 1 VIAL, GLASS2026-07-130Current