FDA.reportPublic FDA data

Otulfi 130 MG in 26 ML Injection

RxCUI
2702624
RxNorm name
Otulfi 130 MG in 26 ML Injection
Display name
Otulfi 130 MG in 26 ML Injection
Full name
Otulfi 130 MG in 26 ML Injection
Term type
PSN
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
761379Otulfiustekinumab-aauz351(k) InterchangeableRx2026-09-01

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
853130e5-7406-4fd6-8138-ff2179195927Otulfi 130 MG in 26 ML Injection [PSN] · 26 ML ustekinumab-aauz 5 MG/ML Injection [Otulfi] [SBD] · Otulfi 130 MG per 26 ML Injection [SY] · Otulfi 5 MG/ML per 26 ML Injection [SY]44These highlights do not include all the information needed to use OTULFI safely and effectively. See full prescribing information for OTULFI. OTULFI (ustekinumab-aauz) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 OTULFI (ustekinumab-aauz) 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 meaningful diffe20260216