Glimepiride
NDC Package 42291-307-90

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Glimepiride is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Marketed by Avkare, Inc., this product is identified by NDC 42291-307 and is authorized under FDA application ANDA077911.

Identification & Billing

NDC Package Code
42291-307-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
42291-307
11-Digit Billing Format
42291030790

Clinical Specifications

Proprietary Name
Glimepiride
Dosage Form
-
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
Avkare, Inc.
FDA Application #
ANDA077911
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-22-2009
End Marketing Date
07-31-2012
Listing Expiration
07-31-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-307-90 identifies a specific commercial package of 90 tablet in 1 bottle of Glimepiride, labeled by Avkare, 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 Avkare, Inc. on September 22, 2009. The current certification is valid through July 31, 2012.

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 Avkare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291030790. 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)
42291-307-90
11-Digit CMS (5-4-2)
42291-0307-90

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