Quick answers
- What is Otulfi?
- Otulfi is a brand name of Ustekinumab, a prescription medicine. The FDA NDC Directory lists 4 Otulfi products in 3 strengths and forms.
- Who makes Otulfi?
- Fresenius Kabi USA holds the FDA application for Otulfi (BLA761379, approved September 27, 2024).
- Is there a generic or store brand of Otulfi?
- Yes. The FDA NDC Directory lists 29 other products with the same active ingredients, strength and form as a Otulfi product. Ask your pharmacist whether one is right for you.
- Has Otulfi been recalled?
- No recall linked to Otulfi products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Otulfi is
Each Otulfi product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ustekinumab · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ustekinumab 130 mg/26 mL solution (intravenous) | Otulfi | 3 products, 2 companies | — |
| ustekinumab 45 mg/0.5 mL injection, solution (subcutaneous) | Otulfi | 15 products, 8 companies | — |
| ustekinumab 90 mg/mL injection, solution (subcutaneous) | Otulfi | 11 products, 9 companies | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ustekinumab →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA761379 | Fresenius Kabi USA | September 27, 2024 | 4 |
Companies that list Otulfi
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Otulfi products.
- Fresenius Kabi USA, LLC4 products
Recalls
No recall linked to Otulfi products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.