FDA.reportPublic FDA data

Selarsdi 45 MG per 0.5 ML Injection

RxCUI
2726118
RxNorm name
Selarsdi 45 MG per 0.5 ML Injection
Display name
Selarsdi 45 MG per 0.5 ML Injection
Full name
Selarsdi 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
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: 2726118

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
87f75b59-e48b-47c7-a4c0-5fe5965660e7Selarsdi 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
87f75b59-e48b-47c7-a4c0-5fe5965660e7Selarsdi 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 Injection [Selarsdi]SBD13These 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-a4c0-5fe5965660e7Selarsdi 90 MG/ML 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