Dexrazoxane Injection, Powder, Lyophilized, For Solution
NDC Package 68083-388-01

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

Package Information

Dexrazoxane (dexrazoxane for injection) injection is dexrazoxane is used to reduce the risk and severity of heart damage caused by doxorubicin treatment and similar cancer chemotherapy medications. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-388 and is authorized under FDA application ANDA207321.

Identification & Billing

NDC Package Code
68083-388-01
Package Description
1 VIAL in 1 CARTON / 25 mL in 1 VIAL
Product Code
68083-388
11-Digit Billing Format
68083038801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dexrazoxane
Non-Proprietary Name
Dexrazoxane For Injection
Substance Name
Dexrazoxane Hydrochloride
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DEXRAZOXANE HYDROCHLORIDE 250 mg/25mL
Pharmacologic Class
Cytoprotective Agent - [EPC] (Established Pharmacologic Class)
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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA207321
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68083-388-01 identifies a specific commercial package of 1 vial in 1 carton / 25 ml in 1 vial of Dexrazoxane, a human prescription drug labeled by Gland Pharma Limited. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains dexrazoxane hydrochloride 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 Gland Pharma Limited on December 16, 2019. The current certification is valid through December 31, 2026.

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 Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083038801. 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)
68083-388-01
11-Digit CMS (5-4-2)
68083-0388-01

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