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)Rx2026-06-01

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#

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.

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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
08ef1e3e-496f-4b0b-94ee-fbba3cc1985a10 ML tislelizumab-jsgr 10 MG/ML Injection [Tevimbra]SBD12These 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
08ef1e3e-496f-4b0b-94ee-fbba3cc1985aTEVIMBRA 100 MG in 10 ML InjectionPSN12These 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
08ef1e3e-496f-4b0b-94ee-fbba3cc1985aTevimbra 100 MG per 10 ML InjectionSY12These 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
08ef1e3e-496f-4b0b-94ee-fbba3cc1985a10 ML Tevimbra 10 MG/ML InjectionSY12These 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