FDA.reportPublic FDA data

ustekinumab-aekn 90 MG/ML per 0.5 ML Injection

RxCUI
2726116
RxNorm name
ustekinumab-aekn 90 MG/ML per 0.5 ML Injection
Display name
ustekinumab-aekn 90 MG/ML per 0.5 ML Injection
Full name
ustekinumab-aekn 90 MG/ML 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
BLAProprietary nameProper nameLicense typeStatusLatest source
761343Selarsdiustekinumab-aekn351(k) InterchangeableRx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SelarsdiUSTEKINUMAB-AEKNTeva Pharmaceuticals USA, Inc.87f75b59-e48b-47c7-a4c0-5fe5965660e72026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 2726116

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
87f75b59-e48b-47c7-a4c0-5fe5965660e7ustekinumab-aekn 90 MG/ML per 0.5 ML InjectionSY13These highlights do not include all the information needed to use SELARSDI safely and effectively. See full prescribing information for SELARSDI. SELARSDI™ (ustekinumab-aekn) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 SELARSDI (ustekinumab-aekn) 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 meaning20251203
87f75b59-e48b-47c7-a4c0-5fe5965660e70.5 ML ustekinumab-aekn 90 MG/ML InjectionSCD13These highlights do not include all the information needed to use SELARSDI safely and effectively. See full prescribing information for SELARSDI. SELARSDI™ (ustekinumab-aekn) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 SELARSDI (ustekinumab-aekn) 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 meaning20251203
87f75b59-e48b-47c7-a4c0-5fe5965660e7ustekinumab-aekn 45 MG in 0.5 ML InjectionPSN13These highlights do not include all the information needed to use SELARSDI safely and effectively. See full prescribing information for SELARSDI. SELARSDI™ (ustekinumab-aekn) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 SELARSDI (ustekinumab-aekn) 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 meaning20251203
87f75b59-e48b-47c7-a4c0-5fe5965660e7ustekinumab-aekn 45 MG per 0.5 ML InjectionSY13These highlights do not include all the information needed to use SELARSDI safely and effectively. See full prescribing information for SELARSDI. SELARSDI™ (ustekinumab-aekn) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 SELARSDI (ustekinumab-aekn) 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 meaning20251203