Dexrazoxane
NDC Package 55390-014-02

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.

Dexrazoxane is used to reduce the risk and severity of heart damage caused by doxorubicin treatment and similar cancer chemotherapy medications. Marketed by Bedford Laboratories, this product is identified by NDC 55390-014 and is authorized under FDA application ANDA076068.

Identification & Billing

NDC Package Code
55390-014-02
Package Description
1 KIT in 1 PACKAGE * 25 mL in 1 VIAL * 25 mL in 1 VIAL (55390-015-01)
Product Code
55390-014
11-Digit Billing Format
55390001402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Dexrazoxane
Dosage Form
-
Usage Information
Dexrazoxane is used to reduce the risk and severity of heart damage caused by doxorubicin treatment and similar cancer chemotherapy medications. Heart damage limits the length of time you can be treated with doxorubicin. Dexrazoxane allows you to continue doxorubicin treatment for longer. When used for this purpose, dexrazoxane treatment is usually started after you have received several doses of doxorubicin. It is usually not given with the first doses of doxorubicin since doing so may reduce the effectiveness of doxorubicin.

Regulatory & Marketing

Labeler Name
Bedford Laboratories
FDA Application #
ANDA076068
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-31-2005
End Marketing Date
05-31-2012
Listing Expiration
05-31-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55390-014-02 identifies a specific commercial package of 1 kit in 1 package * 25 ml in 1 vial * 25 ml in 1 vial (55390-015-01) of Dexrazoxane, labeled by Bedford Laboratories. 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 Bedford Laboratories on March 31, 2005. The current certification is valid through May 31, 2012.

What are the primary indications for this medication?

Dexrazoxane is used to reduce the risk and severity of heart damage caused by doxorubicin treatment and similar cancer chemotherapy medications. Heart damage limits the length of time you can be treated with doxorubicin. Dexrazoxane allows you to continue doxorubicin treatment for longer. When used for this purpose, dexrazoxane treatment is usually started after you have received several doses of doxorubicin. It is usually not given with the first doses of doxorubicin since doing so may reduce the effectiveness of doxorubicin.

How is this Bedford Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55390001402. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
55390-014-02
11-Digit CMS (5-4-2)
55390-0014-02

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