FDA.reportPublic FDA data

Stelara 45 MG per 0.5 ML Prefilled Syringe

RxCUI
853354
RxNorm name
Stelara 45 MG per 0.5 ML Prefilled Syringe
Display name
Stelara 45 MG per 0.5 ML Prefilled Syringe
Full name
Stelara 45 MG per 0.5 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761044Stelaraustekinumab351(a)Rx2026-07-01
125261Stelaraustekinumab351(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
StelaraUSTEKINUMABJanssen Biotech, Inc.c77a9664-e3bb-4023-b400-127aa53bca2b2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 853354

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
c77a9664-e3bb-4023-b400-127aa53bca2bStelara 45 MG in 0.5 mL Prefilled Syringe [PSN] · 0.5 ML ustekinumab 90 MG/ML Prefilled Syringe [Stelara] [SBD] · 0.5 ML Stelara 90 MG/ML Prefilled Syringe [SY] · Stelara 45 MG per 0.5 ML Prefilled Syringe [SY]447These highlights do not include all the information needed to use STELARA safely and effectively. See full prescribing information for STELARA. STELARA ® (ustekinumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 200920260422