Glyburide-metformin Hydrochloride Tablet
NDC Package 68071-3950-3

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

Package Information

Glyburide-metformin Hydrochloride tablets is glyburide and metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This formulation utilizes a tablet delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-3950 and is authorized under FDA application ANDA079009.

Identification & Billing

NDC Package Code
68071-3950-3
Package Description
30 TABLET in 1 BOTTLE
Product Code
68071-3950
11-Digit Billing Format
68071395003
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-metformin Hydrochloride
Non-Proprietary Name
Glyburide-metformin Hydrochloride
Substance Name
Glyburide; Metformin Hydrochloride
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)
Pharmacologic Class
Usage Information
Glyburide and metformin hydrochloride tablets is 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 #
ANDA079009
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2024
Listing Expiration
12-31-2027
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 68071-3950-3 identifies a specific commercial package of 30 tablet in 1 bottle of Glyburide-metformin Hydrochloride, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This tablet 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 May 01, 2024. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071395003. 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)
68071-3950-3
11-Digit CMS (5-4-2)
68071-3950-03

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