Glimepiride Tablet
NDC Package 42571-101-05

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

Glimepiride tablets 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 tablet delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-101 and is authorized under FDA application ANDA091220.

Identification & Billing

NDC Package Code
42571-101-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
42571-101
11-Digit Billing Format
42571010105
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glimepiride
Non-Proprietary Name
Glimepiride
Substance Name
Glimepiride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GLIMEPIRIDE 2 mg/1
Pharmacologic Class
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
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA091220
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-13-2013
Listing Expiration
12-31-2026
Exclude Flag
N
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 (42571-101). Click a package code to view its specific billing and regulatory data.

42571-101-01
100 TABLET in 1 BOTTLE

* 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 42571-101-05 identifies a specific commercial package of 500 tablet in 1 bottle of Glimepiride, a human prescription drug labeled by Micro Labs Limited. This tablet is formulated for oral 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 Micro Labs Limited on June 13, 2013. 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 Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571010105. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
42571-101-05
11-Digit CMS (5-4-2)
42571-0101-05

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