FDA.reportPublic FDA data

Simponi Aria 50 MG in 4 mL Injection

RxCUI
1431647
RxNorm name
Simponi Aria 50 MG in 4 mL Injection
Display name
Simponi Aria 50 MG in 4 mL Injection
Full name
Simponi Aria 50 MG in 4 mL Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125433Simponi Ariagolimumab351(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#

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
SIMPONI ARIAGOLIMUMABJanssen Biotech, Inc.9e260a47-55af-4c92-8d88-a86ccc767fff2025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1431647

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9e260a47-55af-4c92-8d88-a86ccc767fffSimponi Aria 50 MG in 4 mL InjectionPSN28These highlights do not include all the information needed to use SIMPONI ARIA safely and effectively. See full prescribing information for SIMPONI ARIA. SIMPONI ARIA ® (golimumab) injection, for intravenous use Initial U.S. Approval: 200920250909
9e260a47-55af-4c92-8d88-a86ccc767fff4 ML Simponi 12.5 MG/ML InjectionSY28These highlights do not include all the information needed to use SIMPONI ARIA safely and effectively. See full prescribing information for SIMPONI ARIA. SIMPONI ARIA ® (golimumab) injection, for intravenous use Initial U.S. Approval: 200920250909
9e260a47-55af-4c92-8d88-a86ccc767fff4 ML golimumab 12.5 MG/ML Injection [Simponi]SBD28These highlights do not include all the information needed to use SIMPONI ARIA safely and effectively. See full prescribing information for SIMPONI ARIA. SIMPONI ARIA ® (golimumab) injection, for intravenous use Initial U.S. Approval: 200920250909
9e260a47-55af-4c92-8d88-a86ccc767fffSimponi Aria 50 MG per 4 ML InjectionSY28These highlights do not include all the information needed to use SIMPONI ARIA safely and effectively. See full prescribing information for SIMPONI ARIA. SIMPONI ARIA ® (golimumab) injection, for intravenous use Initial U.S. Approval: 200920250909