FDA.reportPublic FDA data

guselkumab 100 MG in 1 ML Auto-Injector

RxCUI
2118739
RxNorm name
guselkumab 100 MG in 1 ML Auto-Injector
Display name
guselkumab 100 MG in 1 ML Auto-Injector
Full name
guselkumab 100 MG in 1 ML Auto-Injector
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)Rx2026-06-01

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
TREMFYAGUSELKUMABJanssen Biotech, Inc.1e6dc9ae-1c4c-42d9-87aa-c315ecc51b562026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 2118739

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56guselkumab 100 MG in 1 ML Auto-InjectorPSN28These 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
1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56guselkumab 100 MG per 1 ML Auto-InjectorSY28These 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
1e6dc9ae-1c4c-42d9-87aa-c315ecc51b561 ML guselkumab 100 MG/ML Auto-InjectorSCD28These 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