FDA.reportPublic FDA data

golimumab 50 MG in 0.5 ML Prefilled Syringe

RxCUI
848160
RxNorm name
golimumab 50 MG in 0.5 ML Prefilled Syringe
Display name
golimumab 50 MG in 0.5 ML Prefilled Syringe
Full name
golimumab 50 MG in 0.5 ML Prefilled Syringe
Term type
PSN
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)Rx2026-06-01

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
SimponiGOLIMUMABJanssen Biotech, Inc.f86cb4a7-c358-4136-ae57-b32bda9bba002025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 848160

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f86cb4a7-c358-4136-ae57-b32bda9bba00golimumab 50 MG in 0.5 ML Prefilled SyringePSN42These 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
f86cb4a7-c358-4136-ae57-b32bda9bba000.5 ML golimumab 100 MG/ML Prefilled SyringeSCD42These 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
f86cb4a7-c358-4136-ae57-b32bda9bba00golimumab 50 MG per 0.5 ML Prefilled SyringeSY42These 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