Glipizide Tablet, Extended Release
NDC Package 0049-1582-01

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.

Glipizide tablets is glipizide 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, extended release delivery system. Marketed by Roerig, this product is identified by NDC 0049-1582.

Identification & Billing

NDC Package Code
0049-1582-01
Package Description
150000 TABLET, EXTENDED RELEASE in 1 DRUM
Product Code
0049-1582
11-Digit Billing Format
00049158201

Clinical Specifications

Proprietary Name
Glipizide
Non-Proprietary Name
Glipizide
Substance Name
Glipizide
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Active Ingredient(s)
GLIPIZIDE 10 mg/1
Usage Information
Glipizide 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. Glipizide 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
Roerig
Product Type
Drug For Further Processing
Marketing Category
EXPORT ONLY - A product that is only exported and not marketed in the United States.
Start Marketing Date
05-09-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0049-1582-01 identifies a specific commercial package of 150000 tablet, extended release in 1 drum of Glipizide (UNFINISHED drug), drug for further processing labeled by Roerig. This tablet, extended release is formulated for use and contains glipizide 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 Roerig on May 09, 2013. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Glipizide 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. Glipizide 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 Roerig product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00049158201. 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 (4-4-2)
0049-1582-01
11-Digit CMS (5-4-2)
00049-1582-01

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