FDA.reportPublic FDA data

0.5 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]

RxCUI
848164
RxNorm name
0.5 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]
Display name
0.5 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]
Full name
0.5 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125289Simponigolimumab351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
f86cb4a7-c358-4136-ae57-b32bda9bba00Simponi 50 MG in 0.5 mL Prefilled Syringe [PSN] · 0.5 ML golimumab 100 MG/ML Prefilled Syringe [Simponi] [SBD] · 0.5 ML Simponi 100 MG/ML Prefilled Syringe [SY] · Simponi 50 MG per 0.5 ML Prefilled Syringe [SY]442These highlights do not include all the information needed to use SIMPONI safely and effectively. See full prescribing information for SIMPONI. SIMPONI ® (golimumab) injection, for subcutaneous use Initial U.S. Approval: 200920251029