FDA.reportPublic FDA data

1 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi]

RxCUI
2705401
RxNorm name
1 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi]
Display name
1 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi]
Full name
1 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi]
Term type
SBD
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) InterchangeableRx2026-07-01

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SelarsdiUSTEKINUMAB-AEKNTeva Pharmaceuticals USA, Inc.87f75b59-e48b-47c7-a4c0-5fe5965660e72026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 2705401
SELARSDIUSTEKINUMAB-AEKNA-S Medication Solutionsb3b483f4-3426-4d6d-97ae-39848ec1bfae2025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 2705401

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 IDRxNorm mappingsTermsSPL versionLabelEffective
87f75b59-e48b-47c7-a4c0-5fe5965660e7Selarsdi 90 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi] [SBD] · Selarsdi 90 MG per 1 ML Prefilled Syringe [SY] · Selarsdi 90 MG/ML per 1 ML Prefilled Syringe [SY]413These 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
b3b483f4-3426-4d6d-97ae-39848ec1bfaeSelarsdi 90 MG/ML in 1 ML Prefilled Syringe [PSN] · 1 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe [Selarsdi] [SBD] · Selarsdi 90 MG per 1 ML Prefilled Syringe [SY] · Selarsdi 90 MG/ML per 1 ML Prefilled Syringe [SY]41These 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 meaning20251120