NDC Package 10135-824-05 Metformin Hydrochloride

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

10135-824-05

Package Description:

500 TABLET, EXTENDED RELEASE in 1 BOTTLE

Product Code:

10135-824

Proprietary Name:

Metformin Hydrochloride

Non-Proprietary Name:

Metformin Hydrochloride

Substance Name:

Metformin Hydrochloride

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.

11-Digit NDC Billing Format:

10135082405

Product Type:

Human Prescription Drug

Labeler Name:

Marlex Pharmaceuticals, Inc.

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

METFORMIN HYDROCHLORIDE 750 mg/1

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA202306

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

08-01-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

10135 - Marlex Pharmaceuticals, Inc.
- 10135-824 - Metformin Hydrochloride
  - 10135-824-05 - 500 TABLET, EXTENDED RELEASE in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
10135-824-10	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE
10135-824-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 10135-824-05?

The NDC Packaged Code 10135-824-05 is assigned to a package of 500 tablet, extended release in 1 bottle of Metformin Hydrochloride, a human prescription drug labeled by Marlex Pharmaceuticals, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

Is NDC 10135-824 included in the NDC Directory?

Yes, Metformin Hydrochloride with product code 10135-824 is active and included in the NDC Directory. The product was first marketed by Marlex Pharmaceuticals, Inc. on August 01, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 10135-824-05?

The 11-digit format is 10135082405. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	10135-824-05	5-4-2	10135-0824-05

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