Glyburide Tablet
NDC Package 68382-656-01

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

Glyburide tablets is glyburide 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 Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 68382-656 and is authorized under FDA application ANDA206749.

Identification & Billing

NDC Package Code
68382-656-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
68382-656
11-Digit Billing Format
68382065601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Glyburide
Non-Proprietary Name
Glyburide
Substance Name
Glyburide
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)
GLYBURIDE 1.25 mg/1
Pharmacologic Class
Usage Information
Glyburide 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. Glyburide 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
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206749
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-02-2016
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 (68382-656). Click a package code to view its specific billing and regulatory data.

68382-656-05
500 TABLET in 1 BOTTLE
68382-656-06
30 TABLET in 1 BOTTLE
68382-656-10
1000 TABLET in 1 BOTTLE
68382-656-16
90 TABLET in 1 BOTTLE
68382-656-77
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (68382-656-30)

* 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 68382-656-01 identifies a specific commercial package of 100 tablet in 1 bottle of Glyburide, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This tablet is formulated for oral use and contains glyburide 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 Zydus Pharmaceuticals (usa) Inc. on June 02, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Glyburide 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. Glyburide 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 Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382065601. 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)
68382-656-01
11-Digit CMS (5-4-2)
68382-0656-01

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