What is NDC 67457-583?

67457-583 is the product NDC for Fondaparinux Sodium, Fondaparinux sodium 5 mg/.4mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fondaparinux Sodium?

23 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fondaparinux Sodium NDC 67457-583 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-583Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0583Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
67457-583-04	6745705830467457058304	10 SYRINGE, GLASS in 1 CARTON (67457-583-04) / .4 mL in 1 SYRINGE, GLASS (67457-583-00)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 — 5 mg/.4mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: Mylan Institutional LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021345
Marketing start: Jan 5, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Factor Xa Inhibitors (Mechanism)
Identifiers: Product ID 67457-583_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.

How CPT relates to drug billing

NDC on a medical claim

N467457058304 followed by a unit qualifier and the quantity

Package 67457-0583-04. 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 Dec 15, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 67457-583

What is NDC 67457-583?: 67457-583 is the product NDC for Fondaparinux Sodium, Fondaparinux sodium 5 mg/.4mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fondaparinux Sodium.
What is the active ingredient?: Fondaparinux sodium.
Who is the labeler?: Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fondaparinux Sodium?: 23 other product NDCs are listed under this name. See all Fondaparinux Sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fondaparinux Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fondaparinux Sodium	Fondaparinux sodium 2.5 mg/.5mL	InjectionSubcutaneous	Sandoz Inc.	0781-3443	00781-3443-1200781-3443-95
Fondaparinux Sodium	Fondaparinux sodium 5 mg/.4mL	InjectionSubcutaneous	Sandoz Inc.	0781-3454	00781-3454-1200781-3454-95
Fondaparinux Sodium	Fondaparinux sodium 7.5 mg/.6mL	InjectionSubcutaneous	Sandoz Inc.	0781-3465	00781-3465-1200781-3465-95
Fondaparinux Sodium	Fondaparinux sodium 10 mg/.8mL	InjectionSubcutaneous	Sandoz Inc.	0781-3476	00781-3476-1200781-3476-95
fondaparinux sodium	Fondaparinux sodium 2.5 mg/.5mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-154	11797-0154-0611797-0154-09
fondaparinux sodium	Fondaparinux sodium 5 mg/.4mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-155	11797-0155-0611797-0155-09
fondaparinux sodium	Fondaparinux sodium 7.5 mg/.6mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-156	11797-0156-0611797-0156-09
fondaparinux sodium	Fondaparinux sodium 10 mg/.8mL	Injection, SolutionSubcutaneous	Italfarmaco S.p.A	11797-157	11797-0157-0611797-0157-09
fondaparinux sodium	Fondaparinux sodium 2.5 mg/.5mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1514	70710-1514-0670710-1514-09
fondaparinux sodium	Fondaparinux sodium 5 mg/.4mL	Injection, SolutionSubcutaneous	Zydus Pharmaceuticals (USA) Inc.	70710-1515	70710-1515-0670710-1515-09

All 24 Fondaparinux Sodium NDCs

Other NDCs under NDA 021345

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021345
Product	Strength	Form · route	Labeler	Product NDC
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
Arixtrafondaparinux sodium	Fondaparinux sodium 10 mg/.8mL	Injection, SolutionSubcutaneous	Mylan Institutional LLC	67457-595
Fondaparinux Sodium	Fondaparinux sodium 2.5 mg/.5mL	Injection, SolutionSubcutaneous	Mylan Institutional LLC	67457-582
Fondaparinux Sodium	Fondaparinux sodium 7.5 mg/.6mL	Injection, SolutionSubcutaneous	Mylan Institutional LLC	67457-584
Fondaparinux Sodium	Fondaparinux sodium 10 mg/.8mL	Injection, SolutionSubcutaneous	Mylan Institutional LLC	67457-585