FDA.reportPublic FDA data

TEVIMBRA

Product NDC
72579-125
Requested package NDC
72579-125-00
11-digit product format
725790125
Labeler code
72579
Product ID
72579-125_da394a19-878c-47c2-ba3d-5934dbb11fc6
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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761232Tevimbratislelizumab-jsgr351(a)Rx2026-10-01

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 startSampleExclude flagStatus
72579-125-00725790125001 VIAL, GLASS in 1 CARTON (72579-125-00) / 15 mL in 1 VIAL, GLASS2026-07-13NoNoCurrent