FDA.reportPublic FDA data

1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi]

RxCUI
2702613
RxNorm name
1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi]
Display name
1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi]
Full name
1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
853130e5-7406-4fd6-8138-ff2179195927Otulfi 90 MG in 1 ML Prefilled Syringe [PSN] · 1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [Otulfi] [SBD] · Otulfi 90 MG per 1 ML Prefilled Syringe [SY] · Otulfi 90 MG/ML per 1 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