Glimepiride
NDC Package 43063-034-30

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 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 Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 43063-034 and is authorized under FDA application ANDA077091.

Identification & Billing

NDC Package Code
43063-034-30
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
43063-034
11-Digit Billing Format
43063003430
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

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
Pd-rx Pharmaceuticals, Inc.
FDA Application #
ANDA077091
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-06-2005
End Marketing Date
08-17-2018
Listing Expiration
08-17-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43063-034). Click a package code to view its specific billing and regulatory data.

43063-034-90
90 TABLET in 1 BOTTLE, PLASTIC

* 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 43063-034-30 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Glimepiride, labeled by Pd-rx Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Pd-rx Pharmaceuticals, Inc. on October 06, 2005. The current certification is valid through August 17, 2018.

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 Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43063003430. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
43063-034-30
11-Digit CMS (5-4-2)
43063-0034-30

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