FDA.reportPublic FDA data

Stelara 45 MG in 0.5 mL Injection

RxCUI
1654079
RxNorm name
Stelara 45 MG in 0.5 mL Injection
Display name
Stelara 45 MG in 0.5 mL Injection
Full name
Stelara 45 MG in 0.5 mL Injection
Term type
PSN
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: 1654079

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 Injection [PSN] · 0.5 ML ustekinumab 90 MG/ML Injection [Stelara] [SBD] · 0.5 ML Stelara 90 MG/ML Injection [SY] · Stelara 45 MG per 0.5 ML Injection [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