ustekinumab-aauz 45 MG per 0.5 ML Injection

RxCUI: 2724429
RxNorm name: ustekinumab-aauz 45 MG per 0.5 ML Injection
Display name: ustekinumab-aauz 45 MG per 0.5 ML Injection
Full name: ustekinumab-aauz 45 MG per 0.5 ML Injection
Term type: SY
Status: DailyMed mapping
Updated: 2026-06-04 23:39:07

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Otulfi	USTEKINUMAB-AAUZ	Fresenius Kabi USA, LLC	853130e5-7406-4fd6-8138-ff2179195927	2026-02-16	Warnings, Adverse reactions	Exact identifier rxcui: 2724429

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
853130e5-7406-4fd6-8138-ff2179195927	ustekinumab-aauz 45 MG in 0.5 ML Injection [PSN] · 0.5 ML ustekinumab-aauz 90 MG/ML Injection [SCD] · ustekinumab-aauz 45 MG per 0.5 ML Injection [SY]	3	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