Rosiglitazone Maleate Powder
NDC Package 55111-063-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Rosiglitazone Maleate powders is rosiglitazone is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This formulation utilizes a powder delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 55111-063.

Identification & Billing

NDC Package Code
55111-063-00
Package Description
1 kg in 1 DRUM
Product Code
55111-063
11-Digit Billing Format
55111006300

Clinical Specifications

Proprietary Name
Rosiglitazone Maleate
Non-Proprietary Name
Rosiglitazone Maleate
Substance Name
Rosiglitazone Maleate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ROSIGLITAZONE MALEATE 1 kg/kg
Usage Information
Rosiglitazone is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Rosiglitazone belongs to the class of drugs known as glitazones. It lowers blood sugar by helping to restore your body's proper response to insulin.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-21-2011
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 55111-063-00 identifies a specific commercial package of 1 kg in 1 drum of Rosiglitazone Maleate (UNFINISHED drug), a bulk ingredient labeled by Dr. Reddy's Laboratories Limited. This powder is formulated for use and contains rosiglitazone maleate 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 Limited on September 21, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Rosiglitazone is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Rosiglitazone belongs to the class of drugs known as glitazones. It lowers blood sugar by helping to restore your body's proper response to insulin.

How is this Dr. Reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111006300. 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)
55111-063-00
11-Digit CMS (5-4-2)
55111-0063-00

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