Quick answers
- What is Otrexup?
- Otrexup is a brand name of Methotrexate, a prescription medicine. The FDA NDC Directory lists 7 Otrexup products in 7 strengths and forms.
- Who makes Otrexup?
- Cosette holds the FDA application for Otrexup (NDA204824, approved October 11, 2013).
- Is there a generic or store brand of Otrexup?
- Other products of Methotrexate are listed with the FDA, but none in exactly the same strength and form as a Otrexup product.
- Has Otrexup been recalled?
- No recall linked to Otrexup products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Otrexup is
Each Otrexup 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.
Methotrexate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| methotrexate 10 mg/0.4 mL injection, solution (subcutaneous) | Otrexup | None listed | DailyMed |
| methotrexate 12.5 mg/0.4 mL injection, solution (subcutaneous) | Otrexup | None listed | DailyMed |
| methotrexate 15 mg/0.4 mL injection, solution (subcutaneous) | Otrexup | None listed | DailyMed |
| methotrexate 17.5 mg/0.4 mL injection, solution (subcutaneous) | Otrexup | None listed | DailyMed |
| methotrexate 20 mg/0.4 mL injection, solution (subcutaneous) | Otrexup | None listed | DailyMed |
| methotrexate 22.5 mg/0.4 mL injection, solution (subcutaneous) | Otrexup | None listed | DailyMed |
| methotrexate 25 mg/0.4 mL injection, solution (subcutaneous) | Otrexup | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Methotrexate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA204824 | Cosette | October 11, 2013 | 7 |
Companies that list Otrexup
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Otrexup products.
- Antares Pharma, Inc.7 products
Recalls
No recall linked to Otrexup 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.