Medicine
Fondaparinux 10 mg/0.8 mL injection
Fondaparinux 10 mg/0.8 mL injection is a generic prescription medicine for subcutaneous use, made by 6 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Fondaparinux
- Brand
- Sold under the generic name
- Strength
- 10 mg/0.8 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 2 syringes of 0.8 mL, 10 syringes of 0.8 mL and 8 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaEugiaIndiaZydus LifesciencesIndiaItalfarmaco Sp ASandozMylan Institutional
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AX05 Fondaparinux
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 July 2011
- Identifiers
- RxCUI 861356, 861360, 861363 +1DailyMed set ID 8ea61d0d-4403-4d9f-a946-85a459cc0aa0, 58789e3d-e5bc-4c2e-a527-495a252fcecd, baa50757-a927-4d56-a933-5d7798fe6ab0 +3NDC 55150-233, 11797-157, 0781-3476 +3Application ANDA206918, ANDA208615, ANDA206812 +2
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 2 syringe in 1 carton / .8 mL in 1 syringe | 55111-681-02 | Dr. Reddy's LaboratoriesIndia | 14 July 2011 |
| 10 syringe in 1 carton / .8 mL in 1 syringe | 55111-681-10 | Dr. Reddy's LaboratoriesIndia | 14 July 2011 |
| 2 syringe, glass in 1 carton / .8 mL in 1 syringe, glass | 55150-233-02 | EugiaIndia | 26 December 2017 |
| 10 syringe, glass in 1 carton / .8 mL in 1 syringe, glass | 55150-233-10 | EugiaIndia | 26 December 2017 |
| 10 syringe in 1 carton / .8 mL in 1 syringe | 70710-1517-6 | Zydus LifesciencesIndia | 6 February 2019 |
| 2 syringe in 1 carton / .8 mL in 1 syringe | 70710-1517-9 | Zydus LifesciencesIndia | 6 February 2019 |
| 10 syringe in 1 carton / .8 mL in 1 syringe | 11797-157-06 | Italfarmaco Sp A | 6 February 2019 |
| 2 syringe in 1 carton / .8 mL in 1 syringe | 11797-157-09 | Italfarmaco Sp A | 6 February 2019 |
| 10 syringe, glass in 1 carton / .8 mL in 1 syringe, glass | 67457-585-08 | Mylan Institutional | 5 January 2015 |
| 2 syringe in 1 carton / .8 mL in 1 syringe | 0781-3476-12 | Sandoz | 18 June 2019 |
| 10 syringe in 1 carton / .8 mL in 1 syringe | 0781-3476-95 | Sandoz | 18 June 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Fondaparinux 10 mg/0.8 mL injection.
Other strengths and forms of Fondaparinux
Clinical summary
Fondaparinux is a factor Xa inhibitor indicated for prophylaxis of deep vein thrombosis (DVT) in adult patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery, among other approved uses. MedsAcross supplies Fondaparinux for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FondaparinuxFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Fondaparinux Sodium prescribing information (Mylan Institutional) · U.S. National Library of Medicine, DailyMed
- Arixtra: European public assessment report (EPAR) · European Medicines Agency
Need Fondaparinux 10 mg/0.8 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.