Glimepiride Powder
NDC Package 58624-0708-0

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.

Glimepiride powders is glimepiride 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 Shandong Xinhua Pharmaceutical Co., Ltd., this product is identified by NDC 58624-0708.

Identification & Billing

NDC Package Code
58624-0708-0
Package Description
20 kg in 1 DRUM
Product Code
58624-0708
11-Digit Billing Format
58624070800

Clinical Specifications

Proprietary Name
Glimepiride
Non-Proprietary Name
Glimepiride
Substance Name
Glimepiride
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)
GLIMEPIRIDE 1 kg/kg
Usage Information
Glimepiride is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. 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. Glimepiride belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.

Regulatory & Marketing

Labeler Name
Shandong Xinhua 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
05-09-2024
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 58624-0708-0 identifies a specific commercial package of 20 kg in 1 drum of Glimepiride (UNFINISHED drug), a bulk ingredient labeled by Shandong Xinhua Pharmaceutical Co., Ltd.. This powder is formulated for use and contains glimepiride 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 Shandong Xinhua Pharmaceutical Co., Ltd. on May 09, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Glimepiride is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. 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. Glimepiride belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.

How is this Shandong Xinhua Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58624070800. 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 (5-4-1)
58624-0708-0
11-Digit CMS (5-4-2)
58624-0708-00

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