Metformin Hydrochloride Extended-release 500mg Tablet, Extended Release
NDC Package 17224-311-28

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

Package Information

Metformin Hydrochloride Extended-release 500mg (metformin hydrochloride) tablets is metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. This formulation utilizes a tablet, extended release delivery system. Marketed by Calvin Scott & Co., Inc., this product is identified by NDC 17224-311 and is authorized under FDA application ANDA078321.

Identification & Billing

NDC Package Code
17224-311-28
Package Description
28 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
17224-311
11-Digit Billing Format
17224031128
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

Clinical Specifications

Proprietary Name
Metformin Hydrochloride Extended-release 500mg
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 is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in patients with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Metformin works by helping to restore your body's proper response to the insulin you naturally produce. It also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb.. This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. Metformin may be used with lifestyle changes such as diet and exercise to prevent diabetes in people who are at high risk for becoming diabetic. It is also used in women with a certain disease of the ovaries (polycystic ovarian syndrome). Metformin may make menstrual cycles more regular and increase fertility.

Regulatory & Marketing

Labeler Name
Calvin Scott & Co., Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078321
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-08-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17224-311-28 identifies a specific commercial package of 28 tablet, extended release in 1 bottle of Metformin Hydrochloride Extended-release 500mg, a human prescription drug labeled by Calvin Scott & Co., Inc.. 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 Calvin Scott & Co., Inc. on June 08, 2017. The current certification is valid through December 31, 2026.

How is this Calvin Scott & Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17224031128. 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)
17224-311-28
11-Digit CMS (5-4-2)
17224-0311-28

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