Otulfi 45 mg/.5mL
ustekinumab-aauz · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
No Recall History
Plain English
Otulfi is a injection, solution containing ustekinumab-aauz at 45 mg/.5mL, taken subcutaneous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Otulfi
- Generic Name
- ustekinumab-aauz
- NDC Code (Product)
65219-822- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 45 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761379
- Drug Class
- Interleukin-12 Antagonist [EPC]; Interleukin-23 Antagonist [EPC]
- Marketing Start
- 09/29/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
accidental exposure to product2 reports
anxiety2 reports
exposure via skin contact2 reports
pain2 reports
treatment failure2 reports
abdominal discomfort1 reports
acute kidney injury1 reports
blindness1 reports
blood chloride decreased1 reports
blood sodium decreased1 reports
Frequently Asked Questions
What is Otulfi used for?
Otulfi contains ustekinumab-aauz. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Otulfi a controlled substance?
Otulfi is not classified as a controlled substance by the DEA.
What is the generic name for Otulfi?
The generic name for Otulfi is ustekinumab-aauz. There are 2 other brand versions of ustekinumab-aauz.
What is the NDC code for Otulfi 45 mg/.5mL?
The NDC (National Drug Code) for Otulfi 45 mg/.5mL is 65219-822, listed by Fresenius Kabi USA, LLC.