ustekinumab 45 MG in 0.5 mL Injection

RxCUI: 1654077
RxNorm name: ustekinumab 45 MG in 0.5 mL Injection
Display name: ustekinumab 45 MG in 0.5 mL Injection
Full name: ustekinumab 45 MG in 0.5 mL Injection
Term type: PSN
Status: DailyMed mapping
Updated: 2026-06-04 23:39:20

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761044	Stelara	ustekinumab	351(a)	Rx	2026-07-01
125261	Stelara	ustekinumab	351(a)	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	USTEKINUMAB	Janssen Biotech, Inc.	23b486eb-f48d-47d4-815e-1313d4ebfbfa	2026-07-23	Warnings, Adverse reactions	Exact identifier rxcui: 1654077
Stelara	USTEKINUMAB	Janssen Biotech, Inc.	c77a9664-e3bb-4023-b400-127aa53bca2b	2026-07-21	Warnings, Adverse reactions	Exact identifier rxcui: 1654077

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
c77a9664-e3bb-4023-b400-127aa53bca2b	ustekinumab 45 MG in 0.5 mL Injection	PSN	47	These highlights do not include all the information needed to use STELARA safely and effectively. See full prescribing information for STELARA. STELARA ® (ustekinumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2009	20260422
c77a9664-e3bb-4023-b400-127aa53bca2b	0.5 ML ustekinumab 90 MG/ML Injection	SCD	47	These highlights do not include all the information needed to use STELARA safely and effectively. See full prescribing information for STELARA. STELARA ® (ustekinumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2009	20260422
c77a9664-e3bb-4023-b400-127aa53bca2b	ustekinumab 45 MG per 0.5 ML Injection	SY	47	These highlights do not include all the information needed to use STELARA safely and effectively. See full prescribing information for STELARA. STELARA ® (ustekinumab) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2009	20260422
23b486eb-f48d-47d4-815e-1313d4ebfbfa	ustekinumab 45 MG per 0.5 ML Injection	SY	6	These highlights do not include all the information needed to use Ustekinumab safely and effectively. See full prescribing information for USTEKINUMAB. Ustekinumab injection, for subcutaneous or intravenous use Initial U.S. Approval: 2009	20260424
23b486eb-f48d-47d4-815e-1313d4ebfbfa	ustekinumab 45 MG in 0.5 mL Injection	PSN	6	These highlights do not include all the information needed to use Ustekinumab safely and effectively. See full prescribing information for USTEKINUMAB. Ustekinumab injection, for subcutaneous or intravenous use Initial U.S. Approval: 2009	20260424
23b486eb-f48d-47d4-815e-1313d4ebfbfa	0.5 ML ustekinumab 90 MG/ML Injection	SCD	6	These highlights do not include all the information needed to use Ustekinumab safely and effectively. See full prescribing information for USTEKINUMAB. Ustekinumab injection, for subcutaneous or intravenous use Initial U.S. Approval: 2009	20260424