Glyburide And Metformin Hydrochloride Tablet, Film Coated
NDC Package 68071-4718-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Glyburide And Metformin Hydrochloride tablets is uSP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This formulation utilizes a tablet, film coated delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-4718 and is authorized under FDA application ANDA077870.

Identification & Billing

NDC Package Code
68071-4718-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
68071-4718
11-Digit Billing Format
68071471803
RxNorm Crosswalk
  • RxCUI: 861753 - glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral Tablet
  • RxCUI: 861753 - glyburide 5 MG / metformin hydrochloride 500 MG Oral Tablet
  • RxCUI: 861753 - glyburide 5 MG / metformin HCl 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Glyburide And Metformin Hydrochloride
Non-Proprietary Name
Glyburide And Metformin Hydrochloride
Substance Name
Glyburide; Metformin Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Glyburide and metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA077870
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2007
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-4718-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Glyburide And Metformin Hydrochloride, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This tablet, film coated is formulated for oral use and contains glyburide; metformin hydrochloride 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 Nucare Pharmaceuticals,inc. on November 14, 2007. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071471803. 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 (5-4-1)
68071-4718-3
11-Digit CMS (5-4-2)
68071-4718-03

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