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 NDC11-digit (billing)PackageCopy
67457-583-046745705830410 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 sodium5 mg/.4mL
Dosage form
Injection, Solution
Route
Subcutaneous
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 67457-583_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 . 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)

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
ProductStrengthForm · routeLabelerProduct NDC
Fondaparinux SodiumFondaparinux sodium 7.5 mg/.6mLInjection, SolutionSubcutaneousMylan Institutional LLC67457-584
Fondaparinux SodiumFondaparinux sodium 2.5 mg/.5mLInjection, SolutionSubcutaneousMylan Institutional LLC67457-582
Fondaparinux SodiumFondaparinux sodium 10 mg/.8mLInjection, SolutionSubcutaneousMylan Institutional LLC67457-585
Arixtrafondaparinux sodiumFondaparinux sodium 10 mg/.8mLInjection, SolutionSubcutaneousMylan Institutional LLC67457-595
Arixtrafondaparinux sodiumFondaparinux sodium 2.5 mg/.5mLInjection, SolutionSubcutaneousMylan Institutional LLC67457-592
Arixtrafondaparinux sodiumFondaparinux sodium 5 mg/.4mLInjection, SolutionSubcutaneousMylan Institutional LLC67457-593
Arixtrafondaparinux sodiumFondaparinux sodium 7.5 mg/.6mLInjection, SolutionSubcutaneousMylan Institutional LLC67457-594

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