FDA.reportPublic FDA data

1 ML guselkumab 100 MG/ML Auto-Injector [Tremfya]

RxCUI
2118741
RxNorm name
1 ML guselkumab 100 MG/ML Auto-Injector [Tremfya]
Display name
1 ML guselkumab 100 MG/ML Auto-Injector [Tremfya]
Full name
1 ML guselkumab 100 MG/ML Auto-Injector [Tremfya]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761061Tremfyaguselkumab351(a)Rx2026-08-01

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
TREMFYAGUSELKUMABJanssen Biotech, Inc.1e6dc9ae-1c4c-42d9-87aa-c315ecc51b562026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 2118741

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
1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56Tremfya 100 MG in 1 ML Auto-Injector [PSN] · 1 ML guselkumab 100 MG/ML Auto-Injector [Tremfya] [SBD] · 1 ML Tremfya 100 MG/ML Auto-Injector [SY] · Tremfya 100 MG per 1 ML Auto-Injector [SY]428These highlights do not include all the information needed to use TREMFYA safely and effectively. See full prescribing information for TREMFYA. TREMFYA ® (guselkumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 201720250929