FDA.reportPublic FDA data

0.5 ML Simponi 100 MG/ML Auto-Injector

RxCUI
1653144
RxNorm name
0.5 ML Simponi 100 MG/ML Auto-Injector
Display name
0.5 ML Simponi 100 MG/ML Auto-Injector
Full name
0.5 ML Simponi 100 MG/ML Auto-Injector
Term type
SY
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)Rx2026-07-01

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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: 1653144

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 Auto-Injector [PSN] · 0.5 ML golimumab 100 MG/ML Auto-Injector [Simponi] [SBD] · 0.5 ML Simponi 100 MG/ML Auto-Injector [SY] · Simponi 50 MG per 0.5 ML Auto-Injector [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