FDA.reportPublic FDA data

10 ML tislelizumab-jsgr 10 MG/ML Injection [Tevimbra]

RxCUI
2677439
RxNorm name
10 ML tislelizumab-jsgr 10 MG/ML Injection [Tevimbra]
Display name
10 ML tislelizumab-jsgr 10 MG/ML Injection [Tevimbra]
Full name
10 ML tislelizumab-jsgr 10 MG/ML Injection [Tevimbra]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

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

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
rxcui: 2677439

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
08ef1e3e-496f-4b0b-94ee-fbba3cc1985aTEVIMBRA 100 MG in 10 ML Injection [PSN] · 10 ML tislelizumab-jsgr 10 MG/ML Injection [Tevimbra] [SBD] · 10 ML Tevimbra 10 MG/ML Injection [SY] · Tevimbra 100 MG per 10 ML Injection [SY]412These highlights do not include all the information needed to use TEVIMBRA safely and effectively. See full prescribing information for TEVIMBRA. TEVIMBRA ® (tislelizumab-jsgr) injection, for intravenous use Initial U.S. Approval: 202420260204