Metformin Tablet, Extended Release
NDC Package 67046-0437-3

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

Package Information

Metformin (metformin er 500 mg) tablets is metformin hydrochloride extended-release tablets are 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. This formulation utilizes a tablet, extended release delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-0437 and is authorized under FDA application ANDA209313.

Identification & Billing

NDC Package Code
67046-0437-3
Package Description
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
67046-0437
11-Digit Billing Format
67046043703

Clinical Specifications

Proprietary Name
Metformin
Non-Proprietary Name
Metformin Er 500 Mg
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 are 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.

Regulatory & Marketing

Labeler Name
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209313
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-16-2026
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 67046-0437-3 identifies a specific commercial package of 30 tablet, extended release in 1 blister pack of Metformin, a human prescription drug labeled by Coupler Llc. 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 Coupler Llc on June 16, 2026. The current certification is valid through December 31, 2027.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046043703. 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)
67046-0437-3
11-Digit CMS (5-4-2)
67046-0437-03

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