NDC 57894-441

ustekinumab 90 mg per 1 mL injection, solution

On the label: Janssen Biotech, Inc..

Switzerland: 1Netherlands: 1Ireland: 1United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Cilag AGSchaffhausen, SwitzerlandMakes it and tests it No problems foundNov 21, 2025 · 8 inspections
Janssen Biologics B.V.Leiden, NetherlandsMakes the active ingredient and tests it Problems found, fixed voluntarilyJun 1, 2023 · 7 inspections
Janssen Sciences Ireland UCCO Cork, IrelandMakes the active ingredient and tests it Problems found, fixed voluntarilyJan 12, 2024 · 5 inspections
Simtra US LLCBloomington, IN, United StatesMakes it Problems found, fixed voluntarilySep 24, 2024 · 12 inspections

Product details

Generic drug
Ustekinumab: every company that makes it
Form
injection, solution, subcutaneous
Strength
90 mg per 1 mL
Approval
BLA BLA125261
On the market since
Apr 1, 2025
Package NDCs
57894-441-01
Official label
DailyMed (National Library of Medicine), updated Oct 16, 2026

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