FDA.reportPublic FDA data

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

RxCUI
1482814
RxNorm name
1 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]
Display name
1 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]
Full name
1 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)Rx2026-06-01

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: 1482814

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f86cb4a7-c358-4136-ae57-b32bda9bba001 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]SBD42These 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-b32bda9bba001 ML Simponi 100 MG/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
f86cb4a7-c358-4136-ae57-b32bda9bba00Simponi 100 MG per 1 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
f86cb4a7-c358-4136-ae57-b32bda9bba00Simponi 100 MG in 1 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