Deferasirox
NDC Package 69097-392-20

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.

Deferasirox is a medication used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-392 and is authorized under FDA application ANDA211852.

Identification & Billing

NDC Package Code
69097-392-20
Package Description
5 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK (69097-392-19)
Product Code
69097-392
11-Digit Billing Format
69097039220

Clinical Specifications

Proprietary Name
Deferasirox
Dosage Form
-
Usage Information
This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). It works by binding to iron, allowing the body to pass extra iron out in the stool. Deferasirox belongs to a class of drugs known as iron-chelating agents. Frequent blood transfusions are often needed in certain types of blood diseases (such as sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. The extra iron can build up in the body and cause problems such as heart failure, liver disease, and diabetes. Getting rid of extra iron can decrease the risk of these diseases.

Regulatory & Marketing

Labeler Name
Cipla Usa Inc.
FDA Application #
ANDA211852
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-14-2020
End Marketing Date
11-22-2023
Listing Expiration
11-22-2023
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 (69097-392). Click a package code to view its specific billing and regulatory data.

69097-392-02
30 TABLET, COATED in 1 BOTTLE

* 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 69097-392-20 identifies a specific commercial package of 5 blister pack in 1 carton / 10 tablet, coated in 1 blister pack (69097-392-19) of Deferasirox, labeled by Cipla Usa 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 Cipla Usa Inc. on June 14, 2020. The current certification is valid through November 22, 2023.

What are the primary indications for this medication?

This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). It works by binding to iron, allowing the body to pass extra iron out in the stool. Deferasirox belongs to a class of drugs known as iron-chelating agents. Frequent blood transfusions are often needed in certain types of blood diseases (such as sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. The extra iron can build up in the body and cause problems such as heart failure, liver disease, and diabetes. Getting rid of extra iron can decrease the risk of these diseases.

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097039220. 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)
69097-392-20
11-Digit CMS (5-4-2)
69097-0392-20

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