Deferasirox Tablet, For Suspension
NDC Package 43598-855-90

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

Deferasirox tablets is a medication used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. This formulation utilizes a tablet, for suspension delivery system. Marketed by Dr. Reddy's Laboratories Inc, this product is identified by NDC 43598-855 and is authorized under FDA application ANDA209878.

Identification & Billing

NDC Package Code
43598-855-90
Package Description
90 TABLET, FOR SUSPENSION in 1 BOTTLE
Product Code
43598-855
11-Digit Billing Format
43598085590
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Deferasirox
Non-Proprietary Name
Deferasirox
Substance Name
Deferasirox
Dosage Form
Tablet, For Suspension - A tablet that forms a suspension when placed in a liquid (formerly referred to as a ‘dispersible tablet’).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEFERASIROX 125 mg/1
Pharmacologic Class
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
Dr. Reddy's Laboratories Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA209878
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43598-855). Click a package code to view its specific billing and regulatory data.

43598-855-10
1000 TABLET, FOR SUSPENSION in 1 BOTTLE
43598-855-30
30 TABLET, FOR SUSPENSION 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 43598-855-90 identifies a specific commercial package of 90 tablet, for suspension in 1 bottle of Deferasirox, a human prescription drug labeled by Dr. Reddy's Laboratories Inc. This tablet, for suspension is formulated for oral use and contains deferasirox 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 Dr. Reddy's Laboratories Inc on November 20, 2019. The current certification is valid through December 31, 2026.

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 Dr. Reddy's Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598085590. 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)
43598-855-90
11-Digit CMS (5-4-2)
43598-0855-90

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