FDA.reportPublic FDA data

dostarlimab-gxly 500 MG in 10 mL Injection

RxCUI
2539972
RxNorm name
dostarlimab-gxly 500 MG in 10 mL Injection
Display name
dostarlimab-gxly 500 MG in 10 mL Injection
Full name
dostarlimab-gxly 500 MG in 10 mL Injection
Term type
PSN
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
761174Jemperlidostarlimab-gxly351(a)Rx2026-10-01

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.

Reported adverse events (FAERS/openFDA)#

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

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
095eab9f-545a-4f12-bfb7-19477fb901a5dostarlimab-gxly 500 MG in 10 mL Injection [PSN] · 10 ML dostarlimab-gxly 50 MG/ML Injection [SCD] · dostarlimab-gxly 500 MG per 10 ML Injection [SY]314These highlights do not include all the information needed to use JEMPERLI safely and effectively. See full prescribing information for JEMPERLI. JEMPERLI (dostarlimab-gxly) injection, for intravenous use Initial U.S. Approval: 202120250902