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)Rx2026-06-01

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
095eab9f-545a-4f12-bfb7-19477fb901a5dostarlimab-gxly 500 MG in 10 mL InjectionPSN14These 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
095eab9f-545a-4f12-bfb7-19477fb901a510 ML dostarlimab-gxly 50 MG/ML InjectionSCD14These 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
095eab9f-545a-4f12-bfb7-19477fb901a5dostarlimab-gxly 500 MG per 10 ML InjectionSY14These 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