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 HistoryFrequently 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.