FDA.reportPublic FDA data

0.5 ML ustekinumab 90 MG/ML Prefilled Syringe

RxCUI
853350
RxNorm name
0.5 ML ustekinumab 90 MG/ML Prefilled Syringe
Display name
0.5 ML ustekinumab 90 MG/ML Prefilled Syringe
Full name
0.5 ML ustekinumab 90 MG/ML Prefilled Syringe
Term type
SCD
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
125261Stelaraustekinumab351(a)Rx2026-06-01
761044Stelaraustekinumab351(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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ustekinumabUSTEKINUMABJanssen Biotech, Inc.23b486eb-f48d-47d4-815e-1313d4ebfbfa2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 853350
StelaraUSTEKINUMABJanssen Biotech, Inc.c77a9664-e3bb-4023-b400-127aa53bca2b2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 853350

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c77a9664-e3bb-4023-b400-127aa53bca2b0.5 ML ustekinumab 90 MG/ML Prefilled SyringeSCD47These 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
c77a9664-e3bb-4023-b400-127aa53bca2bustekinumab 45 MG per 0.5 ML Prefilled SyringeSY47These 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
c77a9664-e3bb-4023-b400-127aa53bca2bustekinumab 45 MG in 0.5 mL Prefilled SyringePSN47These 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
23b486eb-f48d-47d4-815e-1313d4ebfbfa0.5 ML ustekinumab 90 MG/ML Prefilled SyringeSCD6These highlights do not include all the information needed to use Ustekinumab safely and effectively. See full prescribing information for USTEKINUMAB. Ustekinumab injection, for subcutaneous or intravenous use Initial U.S. Approval: 200920260424
23b486eb-f48d-47d4-815e-1313d4ebfbfaustekinumab 45 MG per 0.5 ML Prefilled SyringeSY6These highlights do not include all the information needed to use Ustekinumab safely and effectively. See full prescribing information for USTEKINUMAB. Ustekinumab injection, for subcutaneous or intravenous use Initial U.S. Approval: 200920260424
23b486eb-f48d-47d4-815e-1313d4ebfbfaustekinumab 45 MG in 0.5 mL Prefilled SyringePSN6These highlights do not include all the information needed to use Ustekinumab safely and effectively. See full prescribing information for USTEKINUMAB. Ustekinumab injection, for subcutaneous or intravenous use Initial U.S. Approval: 200920260424