Dexferrum
NDC Package 0517-0134-10

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

Package Information

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

Dexferrum is a medication used to treat "iron-poor" blood (anemia) in people who cannot take iron by mouth because of side effects or because their anemia has not been successfully treated by it. Marketed by American Regent, Inc., this product is identified by NDC 0517-0134 and is authorized under FDA application NDA040024.

Identification & Billing

NDC Package Code
0517-0134-10
Package Description
10 VIAL, SINGLE-DOSE in 1 BOX / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
0517-0134
11-Digit Billing Format
00517013410
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Dexferrum
Dosage Form
-
Usage Information
This medication is used to treat "iron-poor" blood (anemia) in people who cannot take iron by mouth because of side effects or because their anemia has not been successfully treated by it. Low iron levels can occur when the body can't get enough iron from food (poor nutrition, poor absorption) or when there is a large or long-term blood loss (for example, due to hemophilia, stomach bleeding). It is also used by people who have anemia due to long-term kidney disease. Iron is an important part of your red blood cells and is needed to carry oxygen in the body.

Regulatory & Marketing

Labeler Name
American Regent, Inc.
FDA Application #
NDA040024
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-1998
End Marketing Date
04-22-2013
Listing Expiration
04-22-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0517-0134-10 identifies a specific commercial package of 10 vial, single-dose in 1 box / 1 ml in 1 vial, single-dose of Dexferrum, labeled by American Regent, 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 American Regent, Inc. on October 01, 1998. The current certification is valid through April 22, 2013.

What are the primary indications for this medication?

This medication is used to treat "iron-poor" blood (anemia) in people who cannot take iron by mouth because of side effects or because their anemia has not been successfully treated by it. Low iron levels can occur when the body can't get enough iron from food (poor nutrition, poor absorption) or when there is a large or long-term blood loss (for example, due to hemophilia, stomach bleeding). It is also used by people who have anemia due to long-term kidney disease. Iron is an important part of your red blood cells and is needed to carry oxygen in the body.

How is this American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517013410. 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 (4-4-2)
0517-0134-10
11-Digit CMS (5-4-2)
00517-0134-10

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