Active ingredient
Fondaparinux
28 finished FDA listings contain Fondaparinux as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FONDAPARINUX SODIUM
- Dosage forms
- Injection, Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 6
- Strengths listed
- 10 mg/.8ml · 2.5 mg/.5ml · 5 mg/.4ml · 7.5 mg/.6ml
- Brand names in FDA listings
- Arixtra
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 321208
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021345 | MYLAN IRELAND LTD | 2001-12-07 | 8 |
| ANDA 091316 | DR REDDYS LABS LTD | 2011-07-11 | 4 |
| ANDA 206918 | EUGIA PHARMA | 2017-12-26 | 4 |
| ANDA 206812 | HENGRUI PHARMA | 2018-05-15 | 4 |
| ANDA 208615 | SCINOPHARM TAIWAN | 2018-11-14 | 8 |
Official labeling on DailyMed
- FONDAPARINUX SODIUM INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 12 · 2026-09-02
- FONDAPARINUX SODIUM INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS (USA) INC.] · version 20 · 2025-11-17
- FONDAPARINUX SODIUM INJECTION [SANDOZ INC.] · version 18 · 2025-08-29
- ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 13 · 2025-02-03
- FONDAPARINUX SODIUM INJECTION, SOLUTION [EUGIA US LLC] · version 5 · 2024-02-06
- FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED] · version 16 · 2021-09-13
- FONDAPARINUX SODIUM INJECTION, SOLUTION [ITALFARMACO S.P.A] · version 11 · 2021-01-05
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.