FDA.reportPublic FDA data

26 ML ustekinumab 5 MG/ML Injection

RxCUI
1811255
RxNorm name
26 ML ustekinumab 5 MG/ML Injection
Display name
26 ML ustekinumab 5 MG/ML Injection
Full name
26 ML ustekinumab 5 MG/ML Injection
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
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 · 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: 1811255
StelaraUSTEKINUMABJanssen Biotech, Inc.c77a9664-e3bb-4023-b400-127aa53bca2b2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 1811255

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c77a9664-e3bb-4023-b400-127aa53bca2b26 ML ustekinumab 5 MG/ML InjectionSCD47These 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 130 MG per 26 ML InjectionSY47These 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 130 MG in 26 ML InjectionPSN47These 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-1313d4ebfbfa26 ML ustekinumab 5 MG/ML InjectionSCD6These 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 130 MG per 26 ML InjectionSY6These 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 130 MG in 26 ML InjectionPSN6These 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