Metformin Hydrochloride Tablet, Extended Release
NDC Package 25000-101-97

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

Metformin Hydrochloride tablets is metformin Hydrochloride Extended-Release Tablets, USP 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, extended release delivery system. Marketed by Marksans Pharma Limited, this product is identified by NDC 25000-101 and is authorized under FDA application ANDA090295.

Identification & Billing

NDC Package Code
25000-101-97
Package Description
4 BAG in 1 BOX / 2000 TABLET, EXTENDED RELEASE in 1 BAG
Product Code
25000-101
11-Digit Billing Format
25000010197
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
  • RxCUI: 860981 - metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet
  • RxCUI: 860981 - 24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Metformin Hydrochloride
Non-Proprietary Name
Metformin Hydrochloride
Substance Name
Metformin Hydrochloride
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METFORMIN HYDROCHLORIDE 500 mg/1
Pharmacologic Class
Usage Information
Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Marksans Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090295
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-12-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (25000-101). Click a package code to view its specific billing and regulatory data.

25000-101-03
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
25000-101-12
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
25000-101-14
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE
25000-101-98
1 BAG in 1 BOX / 11695 TABLET, EXTENDED RELEASE in 1 BAG

* 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 25000-101-97 identifies a specific commercial package of 4 bag in 1 box / 2000 tablet, extended release in 1 bag of Metformin Hydrochloride, a human prescription drug labeled by Marksans Pharma Limited. This tablet, extended release is formulated for oral use and contains 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 Marksans Pharma Limited on May 12, 2016. The current certification is valid through December 31, 2027.

How is this Marksans Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 25000010197. 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)
25000-101-97
11-Digit CMS (5-4-2)
25000-0101-97

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