Quick answers
- What is Fondaparinux sodium used for?
- The FDA-approved label (Arixtra, Mylan Institutional LLC, December 10, 2024) says: “ARIXTRA is a Factor Xa inhibitor (anticoagulant) 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. • Treatment of DVT or acute pulmonary embolism (PE) in adult patients when administered in conjunction with warfarin sodium. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fondaparinux sodium have a boxed warning?
- Yes. The FDA label for Arixtra has a boxed warning (“WARNING: SPINAL/EPIDURAL HEMATOMAS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Fondaparinux sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fondaparinux sodium been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 30, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fondaparinux sodium?
- 6 companies list prescription products of Fondaparinux sodium in the FDA NDC Directory, including Mylan Institutional LLC, Eugia US LLC and Zydus Pharmaceuticals USA Inc..
What Fondaparinux sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ARIXTRA is a Factor Xa inhibitor (anticoagulant) 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. • Treatment of DVT or acute pulmonary embolism (PE) in adult patients when administered in conjunction with warfarin sodium. …
— FDA label: Arixtra, Mylan Institutional LLC, effective December 10, 2024. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SPINAL/EPIDURAL HEMATOMAS
. Read it on the full label →
7 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 28 in the FDA NDC Directory |
| Brand names | Arixtra |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fondaparinux sodium 10 mg/0.8 mL injection | Generic | $42.48 per mL |
| fondaparinux sodium 10 mg/0.8 mL injection, solution | Generic | $42.48 per mL |
| fondaparinux sodium 2.5 mg/0.5 mL injection | Generic | $12.00–$22.16 per mL 3 packages, lowest to highest |
| fondaparinux sodium 2.5 mg/0.5 mL injection, solution | Generic | $22.16 per mL |
| fondaparinux sodium 7.5 mg/0.6 mL injection | Generic | $42.35 per mL |
| fondaparinux sodium 7.5 mg/0.6 mL injection, solution | Generic | $42.35 per mL |
NADAC list of November 4, 2026; these prices took effect between August 19, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mylan Institutional LLC8 products
- Eugia US LLC4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Sandoz Inc4 products
- Italfarmaco S.p.A4 products
- Dr. Reddy's Laboratories Limited4 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021345 ARIXTRA | Mylan Ireland Ltd | December 7, 2001 | 17, latest December 23, 2024 2024: Efficacy · 2020: Labeling · 2019: Labeling |
Generic approvals (4)
- ANDA091316DR Reddys Labs Ltd · July 11, 2011
- ANDA206918Eugia Pharma · December 26, 2017
- ANDA206812Hengrui Pharma · May 15, 2018
- ANDA208615Scinopharm Taiwan · November 14, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 30, 2022 · Class II · Terminated · D-0020-2023
Subpotent Drug: Out of specification for assay
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC — AuroMedics Pharma LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Arixtra, Mylan Institutional LLC, effective December 10, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →