Prescription drug · NDA AUTHORIZED GENERIC
Fondaparinux Sodium NDC 67457-585
Fondaparinux sodium 10 mg/.8mL · Injection, Solution · Subcutaneous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-585-08 | 67457058508 | 10 SYRINGE, GLASS in 1 CARTON (67457-585-08) / .8 mL in 1 SYRINGE, GLASS (67457-585-00)Marketed from Jan 5, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fondaparinux Sodium
- Generic name (nonproprietary)
- fondaparinux sodium
- Active ingredients
- Fondaparinux sodium — 10 mg/.8mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021345
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 67457-585_9448af58-144f-4611-a462-e8cb12cc7362SPL ID 9448af58-144f-4611-a462-e8cb12cc7362SPL set ID 4b65f642-87f7-4da5-a9c9-02cd1f8d9d16RxCUI 861356, 861360, 861363, 861365UNII X0Q6N9USOZ
- Pharmacologic class
- Factor Xa Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467457058508followed by a unit qualifier and the quantityPackage 67457-0585-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Fondaparinux sodium injection 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. ( 1.1 ) • Treatment of DVT or acute pulmonary embolism (PE) in adult patients when administered in conjunction with warfarin sodium. ( 1.2 , 1.3 ) • Treatment of venous thromboembolism (VTE) in pediatric patients aged 1 year or older weighing at least 10 kg. ( 1.4 ) 1.1 Prophylaxis of Deep Vein Thrombosis in Adult Patients Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021345
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fondaparinux Sodium | Fondaparinux sodium 7.5 mg/.6mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 67457-584 |
| Fondaparinux Sodium | Fondaparinux sodium 2.5 mg/.5mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 67457-582 |
| Fondaparinux Sodium | Fondaparinux sodium 5 mg/.4mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 67457-583 |
| Arixtrafondaparinux sodium | Fondaparinux sodium 10 mg/.8mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 67457-595 |
| Arixtrafondaparinux sodium | Fondaparinux sodium 2.5 mg/.5mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 67457-592 |
| Arixtrafondaparinux sodium | Fondaparinux sodium 5 mg/.4mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 67457-593 |
| Arixtrafondaparinux sodium | Fondaparinux sodium 7.5 mg/.6mL | Injection, SolutionSubcutaneous | Mylan Institutional LLC | 67457-594 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.