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)Rx2026-08-01
761044Stelaraustekinumab351(a)Rx2026-08-01

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.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c77a9664-e3bb-4023-b400-127aa53bca2bustekinumab 45 MG in 0.5 mL Prefilled Syringe [PSN] · 0.5 ML ustekinumab 90 MG/ML Prefilled Syringe [SCD] · ustekinumab 45 MG per 0.5 ML Prefilled Syringe [SY]347These 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-1313d4ebfbfaustekinumab 45 MG in 0.5 mL Prefilled Syringe [PSN] · 0.5 ML ustekinumab 90 MG/ML Prefilled Syringe [SCD] · ustekinumab 45 MG per 0.5 ML Prefilled Syringe [SY]36These 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