FDA.reportPublic FDA data

guselkumab Induction Pack for Crohn's Disease (2 count)

RxCUI
2711637
RxNorm name
guselkumab Induction Pack for Crohn's Disease (2 count)
Display name
guselkumab Induction Pack for Crohn's Disease (2 count)
Full name
guselkumab Induction Pack for Crohn's Disease (2 count)
Term type
PSN
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: 2711637

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-c315ecc51b56{2 (2 ML guselkumab 100 MG/ML Auto-Injector) } Pack [GPCK] · guselkumab Induction Pack for Crohn's Disease (2 count) [PSN] · guselkumab Induction Pack for Crohn's Disease (2 count) [SY]328These 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