Metformin Hydrochloride Tablet
NDC Package 67046-0804-3

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

Package Information

Metformin Hydrochloride 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 delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-0804 and is authorized under FDA application ANDA090564.

Identification & Billing

NDC Package Code
67046-0804-3
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
67046-0804
11-Digit Billing Format
67046080403

Clinical Specifications

Proprietary Name
Metformin Hydrochloride
Non-Proprietary Name
Metformin Hydrochloride
Substance Name
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)
METFORMIN HYDROCHLORIDE 850 mg/1
Pharmacologic Class
Usage Information
Metformin hydrochloride 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 #
ANDA090564
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-10-2026
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 67046-0804-3 identifies a specific commercial package of 30 tablet in 1 blister pack of Metformin Hydrochloride, a human prescription drug labeled by Coupler Llc. This tablet 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 10, 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: 67046080403. 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)
67046-0804-3
11-Digit CMS (5-4-2)
67046-0804-03

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