FDA.reportPublic FDA data

1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe

RxCUI
2702606
RxNorm name
1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe
Display name
1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe
Full name
1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe
Term type
SCD
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) InterchangeableRx2026-07-01

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
USTEKINUMAB-AAUZUSTEKINUMAB-AAUZFresenius Kabi USA, LLCa6d75316-c9a7-49cf-83be-b7b6c6cecf7a2026-02-26Warnings, Adverse reactionsExact identifier
rxcui: 2702606
OtulfiUSTEKINUMAB-AAUZFresenius Kabi USA, LLC853130e5-7406-4fd6-8138-ff21791959272026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 2702606

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 90 MG in 1 ML Prefilled Syringe [PSN] · 1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [SCD] · ustekinumab-aauz 90 MG per 1 ML Prefilled Syringe [SY] · ustekinumab-aauz 90 MG/ML per 1 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 90 MG in 1 ML Prefilled Syringe [PSN] · 1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe [SCD] · ustekinumab-aauz 90 MG per 1 ML Prefilled Syringe [SY] · ustekinumab-aauz 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