Metformin Hydrochloride
NDC Package 68071-2829-9

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Metformin Hydrochloride is tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-2829 and is authorized under FDA application ANDA206145.

Identification & Billing

NDC Package Code
68071-2829-9
Package Description
90 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
68071-2829
11-Digit Billing Format
68071282909
RxNorm Crosswalk
  • RxCUI: 860975 - metFORMIN HCl 500 MG 24HR Extended Release Oral Tablet
  • RxCUI: 860975 - 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet
  • RxCUI: 860975 - metformin HCl 500 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Metformin Hydrochloride
Dosage Form
-
Usage Information
Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release 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.
FDA Application #
ANDA206145
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-27-2018
Listing Expiration
12-31-2024
Exclude Flag
I
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 (68071-2829). Click a package code to view its specific billing and regulatory data.

68071-2829-6
60 TABLET, EXTENDED RELEASE 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 68071-2829-9 identifies a specific commercial package of 90 tablet, extended release in 1 bottle of Metformin Hydrochloride, labeled by Nucare Pharmaceuticals,inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nucare Pharmaceuticals,inc. on October 27, 2018. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071282909. 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)
68071-2829-9
11-Digit CMS (5-4-2)
68071-2829-09

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