Quick answers
- What is Arixtra?
- Arixtra is a brand name of Fondaparinux sodium, a prescription medicine. The FDA NDC Directory lists 4 Arixtra products in 4 strengths and forms.
- Who makes Arixtra?
- Mylan Ireland Ltd holds the FDA application for Arixtra (NDA021345, approved December 7, 2001).
- Is there a generic or store brand of Arixtra?
- Yes. The FDA NDC Directory lists 16 other products with the same active ingredients, strength and form as a Arixtra product, 16 of them generic. Ask your pharmacist whether one is right for you.
- Has Arixtra been recalled?
- No recall linked to Arixtra products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Arixtra is
Each Arixtra 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.
Fondaparinux sodium · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| fondaparinux sodium 10 mg/0.8 mL injection, solution (subcutaneous) | Arixtra | 4 products, 4 companies | DailyMed |
| fondaparinux sodium 2.5 mg/0.5 mL injection, solution (subcutaneous) | Arixtra | 4 products, 4 companies | DailyMed |
| fondaparinux sodium 5 mg/0.4 mL injection, solution (subcutaneous) | Arixtra | 4 products, 4 companies | DailyMed |
| fondaparinux sodium 7.5 mg/0.6 mL injection, solution (subcutaneous) | Arixtra | 4 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Fondaparinux sodium →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021345 | Mylan Ireland Ltd | December 7, 2001 | 4 |
Companies that list Arixtra
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Arixtra products.
- Mylan Institutional LLC4 products
Recalls
No recall linked to Arixtra 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.