Mifepristone Powder
NDC Package 44132-005-01

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 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.

Mifepristone powders is a medication used to control high blood sugar in people who have a certain condition (Cushing's syndrome), and who have failed surgery or cannot have surgery to correct the condition. This formulation utilizes a powder delivery system. Marketed by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., this product is identified by NDC 44132-005.

Identification & Billing

NDC Package Code
44132-005-01
Package Description
5 kg in 1 DRUM
Product Code
44132-005
11-Digit Billing Format
44132000501

Clinical Specifications

Proprietary Name
Mifepristone
Non-Proprietary Name
Mifepristone
Substance Name
Mifepristone
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)
MIFEPRISTONE 1 kg/kg
Usage Information
This medication is used to control high blood sugar in people who have a certain condition (Cushing's syndrome), and who have failed surgery or cannot have surgery to correct the condition. Cushing's syndrome is caused by the body producing too much of a certain hormone (cortisol) which can cause glucose intolerance or type 2 diabetes. Mifepristone works by blocking the effects of cortisol.

Regulatory & Marketing

Labeler Name
Qinhuangdao Zizhu Pharmaceutical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
06-08-2012
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (44132-005). Click a package code to view its specific billing and regulatory data.

44132-005-02
2 kg in 1 DRUM
44132-005-03
1 kg in 1 DRUM
44132-005-04
.5 kg in 1 DRUM
44132-005-05
.1 kg in 1 BAG

* 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 44132-005-01 identifies a specific commercial package of 5 kg in 1 drum of Mifepristone (UNFINISHED drug), a bulk ingredient labeled by Qinhuangdao Zizhu Pharmaceutical Co., Ltd.. This powder is formulated for use and contains mifepristone 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 Qinhuangdao Zizhu Pharmaceutical Co., Ltd. on June 08, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to control high blood sugar in people who have a certain condition (Cushing's syndrome), and who have failed surgery or cannot have surgery to correct the condition. Cushing's syndrome is caused by the body producing too much of a certain hormone (cortisol) which can cause glucose intolerance or type 2 diabetes. Mifepristone works by blocking the effects of cortisol.

How is this Qinhuangdao Zizhu Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44132000501. 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)
44132-005-01
11-Digit CMS (5-4-2)
44132-0005-01

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