Venofer
NDC Package 49230-103-01

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.

Venofer is this medicine is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease. Marketed by Fresenius Medical Care North America, this product is identified by NDC 49230-103 and is authorized under FDA application NDA021135.

Identification & Billing

NDC Package Code
49230-103-01
Package Description
1 VIAL, SINGLE-USE in 1 BOX / 10 mL in 1 VIAL, SINGLE-USE
Product Code
49230-103
11-Digit Billing Format
49230010301

Clinical Specifications

Proprietary Name
Venofer
Dosage Form
-
Usage Information
This medicine is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease. You may need extra iron because of blood loss during kidney dialysis. Your body may also need more iron if you use the drug erythropoietin to help make new red blood cells. Iron is an important part of your red blood cells and is needed to transport oxygen in the body. Many patients with kidney disease cannot get enough iron from food and require injections.

Regulatory & Marketing

Labeler Name
Fresenius Medical Care North America
FDA Application #
NDA021135
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-04-2008
End Marketing Date
11-02-2012
Listing Expiration
11-02-2012
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 (49230-103). Click a package code to view its specific billing and regulatory data.

49230-103-05
5 VIAL, SINGLE-USE in 1 BOX / 10 mL in 1 VIAL, SINGLE-USE
49230-103-10
10 VIAL, SINGLE-USE in 1 BOX / 10 mL in 1 VIAL, SINGLE-USE

* 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 49230-103-01 identifies a specific commercial package of 1 vial, single-use in 1 box / 10 ml in 1 vial, single-use of Venofer, labeled by Fresenius Medical Care North America. 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 Fresenius Medical Care North America on November 04, 2008. The current certification is valid through November 02, 2012.

What are the primary indications for this medication?

This medicine is used to treat "iron-poor" blood (anemia) in people with long-term kidney disease. You may need extra iron because of blood loss during kidney dialysis. Your body may also need more iron if you use the drug erythropoietin to help make new red blood cells. Iron is an important part of your red blood cells and is needed to transport oxygen in the body. Many patients with kidney disease cannot get enough iron from food and require injections.

How is this Fresenius Medical Care North America product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49230010301. 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)
49230-103-01
11-Digit CMS (5-4-2)
49230-0103-01

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