Fondaparinux Sodium Injection, Solution
NDC Package 11797-154-06

11-digit billing NDC: 11797015406
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fondaparinux Sodium injection is  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;in patients undergoing knee replacement surgery;in patients undergoing abdominal surgery who are at risk for thromboembolic complications. This formulation utilizes a injection, solution delivery system. Marketed by Italfarmaco S.p.a, this product is identified by NDC 11797-154 and is authorized under FDA application ANDA208615.

Identification & Billing

NDC Package Code
11797-154-06
Package Description
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (11797-154-02)
Product Code
11797-154
11-Digit Billing Format
11797015406
RxNorm Crosswalk
  • RxCUI: 861356 - fondaparinux sodium 10 MG in 0.8 ML Prefilled Syringe
  • RxCUI: 861356 - 0.8 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe
  • RxCUI: 861356 - fondaparinux sodium 10 MG per 0.8 ML Prefilled Syringe
  • RxCUI: 861360 - fondaparinux sodium 2.5 MG in 0.5 ML Prefilled Syringe
  • RxCUI: 861360 - 0.5 ML fondaparinux sodium 5 MG/ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Fondaparinux Sodium
Non-Proprietary Name
Fondaparinux Sodium
Substance Name
Fondaparinux Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
FONDAPARINUX SODIUM 2.5 mg/.5mL
Pharmacologic Class
Usage Information
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;in patients undergoing knee replacement surgery;in patients undergoing abdominal surgery who are at risk for thromboembolic complications.

Regulatory & Marketing

Labeler Name
Italfarmaco S.p.a
Product Type
Human Prescription Drug
FDA Application #
ANDA208615
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-06-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (11797-154). Click a package code to view its specific billing and regulatory data.

11797-154-09
2 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (11797-154-02)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 11797-154-06 identifies a specific commercial package of 10 syringe in 1 carton / .5 ml in 1 syringe (11797-154-02) of Fondaparinux Sodium, a human prescription drug labeled by Italfarmaco S.p.a. This injection, solution is formulated for subcutaneous use and contains fondaparinux sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Italfarmaco S.p.a on February 06, 2019. The current certification is valid through December 31, 2026.

How is this Italfarmaco S.p.a product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11797015406. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
11797-154-06
11-Digit CMS (5-4-2)
11797-0154-06

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.