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
BLA	Proprietary name	Proper name	License type	Status	Latest source
761379	Otulfi	ustekinumab-aauz	351(k) Interchangeable	Rx	2026-07-01

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
USTEKINUMAB-AAUZ	USTEKINUMAB-AAUZ	Fresenius Kabi USA, LLC	a6d75316-c9a7-49cf-83be-b7b6c6cecf7a	2026-02-26	Warnings, Adverse reactions	Exact identifier rxcui: 2702615
Otulfi	USTEKINUMAB-AAUZ	Fresenius Kabi USA, LLC	853130e5-7406-4fd6-8138-ff2179195927	2026-02-16	Warnings, Adverse reactions	Exact identifier rxcui: 2702615

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
a6d75316-c9a7-49cf-83be-b7b6c6cecf7a	ustekinumab-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]	4	4	These 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-ff2179195927	ustekinumab-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]	4	4	These 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 diffe	20260216