Metformin Hydrochloride Tablet, Coated
NDC Package 83301-0010-2

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 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, coated delivery system. Marketed by Mullan Pharmaceutical Inc., this product is identified by NDC 83301-0010 and is authorized under FDA application ANDA205096.

Identification & Billing

NDC Package Code
83301-0010-2
Package Description
500 TABLET, COATED in 1 BOTTLE
Product Code
83301-0010
11-Digit Billing Format
83301001002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metformin Hydrochloride
Non-Proprietary Name
Metformin Hydrochloride
Substance Name
Metformin Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METFORMIN HYDROCHLORIDE 1000 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
Mullan Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205096
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2024
Listing Expiration
12-31-2026
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 (83301-0010). Click a package code to view its specific billing and regulatory data.

83301-0010-1
100 TABLET, COATED in 1 BOTTLE
83301-0010-3
1000 TABLET, COATED 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 83301-0010-2 identifies a specific commercial package of 500 tablet, coated in 1 bottle of Metformin Hydrochloride, a human prescription drug labeled by Mullan Pharmaceutical Inc.. This tablet, coated 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 Mullan Pharmaceutical Inc. on January 01, 2024. The current certification is valid through December 31, 2026.

How is this Mullan Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83301001002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. 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)
83301-0010-2
11-Digit CMS (5-4-2)
83301-0010-02

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