Prescription drug · ANDA
fondaparinux sodium NDC 11797-154
Fondaparinux sodium 2.5 mg/.5mL · Injection, Solution · Subcutaneous · Italfarmaco S.p.A
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11797-154-06 | 11797015406 | 10 SYRINGE in 1 CARTON (11797-154-06) / .5 mL in 1 SYRINGE (11797-154-02)Marketed from Feb 6, 2019 | |
| 11797-154-09 | 11797015409 | 2 SYRINGE in 1 CARTON (11797-154-09) / .5 mL in 1 SYRINGE (11797-154-02)Marketed from Feb 6, 2019 |
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 — 2.5 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Italfarmaco S.p.A
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208615
- Marketing start
- Listing expires
- Other FDA classes
- Factor Xa Inhibitors (Mechanism)
- Identifiers
- Product ID 11797-154_714aaf0c-95ac-4de9-b8d2-5fdcd1365804SPL ID 714aaf0c-95ac-4de9-b8d2-5fdcd1365804SPL set ID 58789e3d-e5bc-4c2e-a527-495a252fcecdRxCUI 861356, 861360, 861363, 861365UNII X0Q6N9USOZUPC 0311797154068, 0311797154099, 0311797156062, 0311797155096, 0311797156093, 0311797157069, 0311797157090, 0311797155065
- 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
N411797015406followed by a unit qualifier and the quantityPackage 11797-0154-06. 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 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) when administered in conjunction with warfarin. ( 1.2 , 1.3 ) 1.1 Prophylaxis of Deep Vein Thrombosis Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): in patients undergoing hip fracture surgery, including extended prophylaxis; in patients undergoing hip replacement surgery;…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208615
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 2.5 mg/.5mL | Injection, SolutionSubcutaneous | Zydus Pharmaceuticals (USA) Inc. | 70710-1514 |
| fondaparinux sodium | Fondaparinux sodium 5 mg/.4mL | Injection, SolutionSubcutaneous | Zydus Pharmaceuticals (USA) Inc. | 70710-1515 |
| fondaparinux sodium | Fondaparinux sodium 7.5 mg/.6mL | Injection, SolutionSubcutaneous | Zydus Pharmaceuticals (USA) Inc. | 70710-1516 |
| fondaparinux sodium | Fondaparinux sodium 10 mg/.8mL | Injection, SolutionSubcutaneous | Zydus Pharmaceuticals (USA) Inc. | 70710-1517 |
| fondaparinux sodium | Fondaparinux sodium 5 mg/.4mL | Injection, SolutionSubcutaneous | Italfarmaco S.p.A | 11797-155 |
| fondaparinux sodium | Fondaparinux sodium 7.5 mg/.6mL | Injection, SolutionSubcutaneous | Italfarmaco S.p.A | 11797-156 |
| fondaparinux sodium | Fondaparinux sodium 10 mg/.8mL | Injection, SolutionSubcutaneous | Italfarmaco S.p.A | 11797-157 |