Fondaparinux Sodium
NDC Package 43598-607-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Fondaparinux Sodium is fondaparinux is used to treat serious blood clots in the legs and/or lungs. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-607 and is authorized under FDA application ANDA091316.

Identification & Billing

NDC Package Code
43598-607-10
Package Description
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (43598-607-11)
Product Code
43598-607
11-Digit Billing Format
43598060710
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Fondaparinux Sodium
Dosage Form
-
Usage Information
Fondaparinux is used to treat serious blood clots in the legs and/or lungs. It is usually used with another "blood thinner" medication (warfarin). If untreated, blood clots can travel to the lungs, heart, or brain, causing serious (possibly fatal) breathing problems, heart attack, or stroke. This drug may also be used to prevent blood clots after certain surgeries with an increased risk of blood clots (such as hip fracture, abdominal, knee/hip replacement). Fondaparinux is known as a "blood thinner" (anticoagulant). It is a drug similar to heparin that works by blocking certain natural substances in the blood that cause clotting.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
FDA Application #
ANDA091316
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-27-2017
End Marketing Date
12-31-2020
Listing Expiration
12-31-2020
Exclude Flag
D
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 (43598-607). Click a package code to view its specific billing and regulatory data.

43598-607-02
2 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (43598-607-11)

* 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 43598-607-10 identifies a specific commercial package of 10 syringe in 1 carton / .5 ml in 1 syringe (43598-607-11) of Fondaparinux Sodium, labeled by Dr. Reddy's Laboratories Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Dr. Reddy's Laboratories Inc. on July 27, 2017. The current certification is valid through December 31, 2020.

What are the primary indications for this medication?

Fondaparinux is used to treat serious blood clots in the legs and/or lungs. It is usually used with another "blood thinner" medication (warfarin). If untreated, blood clots can travel to the lungs, heart, or brain, causing serious (possibly fatal) breathing problems, heart attack, or stroke. This drug may also be used to prevent blood clots after certain surgeries with an increased risk of blood clots (such as hip fracture, abdominal, knee/hip replacement). Fondaparinux is known as a "blood thinner" (anticoagulant). It is a drug similar to heparin that works by blocking certain natural substances in the blood that cause clotting.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598060710. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
43598-607-10
11-Digit CMS (5-4-2)
43598-0607-10

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