FDA.reportPublic FDA data

1 ML ustekinumab-auub 90 MG/ML Prefilled Syringe

RxCUI
2700691
RxNorm name
1 ML ustekinumab-auub 90 MG/ML Prefilled Syringe
Display name
1 ML ustekinumab-auub 90 MG/ML Prefilled Syringe
Full name
1 ML ustekinumab-auub 90 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761285Wezlanaustekinumab-auub351(k) InterchangeableRx2026-07-01
761331Wezlanaustekinumab-auub351(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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WEZLANAUSTEKINUMAB-AUUBNuvaila Limiteda6c23978-09f0-4796-88f7-d0ce7e3ed04e2026-06-03Warnings, Adverse reactionsExact identifier
rxcui: 2700691

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 IDRxNorm mappingsTermsSPL versionLabelEffective
a6c23978-09f0-4796-88f7-d0ce7e3ed04eustekinumab-auub 90 MG in 1 ML Prefilled Syringe [PSN] · 1 ML ustekinumab-auub 90 MG/ML Prefilled Syringe [SCD] · ustekinumab-auub 90 MG per 1 ML Prefilled Syringe [SY] · ustekinumab-auub 90 MG/ML per 1 ML Prefilled Syringe [SY]48These highlights do not include all the information needed to use WEZLANA™ safely and effectively. See full prescribing information for WEZLANA. WEZLANA™ (ustekinumab-auub) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2023 WEZLANA™ (ustekinumab-auub) 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 meaningful20260524