FDA.reportPublic FDA data

ustekinumab-aauz 45 MG in 0.5 ML Prefilled Syringe

RxCUI
2702615
RxNorm name
ustekinumab-aauz 45 MG in 0.5 ML Prefilled Syringe
Display name
ustekinumab-aauz 45 MG in 0.5 ML Prefilled Syringe
Full name
ustekinumab-aauz 45 MG in 0.5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761379Otulfiustekinumab-aauz351(k) InterchangeableRx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
a6d75316-c9a7-49cf-83be-b7b6c6cecf7austekinumab-aauz 45 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [SCD] · ustekinumab-aauz 45 MG per 0.5 ML Prefilled Syringe [SY] · ustekinumab-aauz 90 MG/ML per 0.5 ML Prefilled Syringe [SY]44These highlights do not include all the information needed to use USTEKINUMAB-AAUZ safely and effectively. See full prescribing information for USTEKINUMAB-AAUZ. USTEKINUMAB-AAUZ injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 This product is OTULFI (ustekinumab-aauz). Ustekinumab-aauz is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and 20260226
853130e5-7406-4fd6-8138-ff2179195927ustekinumab-aauz 45 MG in 0.5 ML Prefilled Syringe [PSN] · 0.5 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [SCD] · ustekinumab-aauz 45 MG per 0.5 ML Prefilled Syringe [SY] · ustekinumab-aauz 90 MG/ML per 0.5 ML Prefilled Syringe [SY]44These highlights do not include all the information needed to use OTULFI safely and effectively. See full prescribing information for OTULFI. OTULFI (ustekinumab-aauz) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 OTULFI (ustekinumab-aauz) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diffe20260216