Glumetza Tablet, Film Coated, Extended Release
NDC Package 68012-003-97

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

Glumetza (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, film coated, extended release delivery system. Marketed by Santarus, Inc., this product is identified by NDC 68012-003 and is authorized under FDA application NDA021748.

Identification & Billing

NDC Package Code
68012-003-97
Package Description
7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
68012-003
11-Digit Billing Format
68012000397
RxNorm Crosswalk
  • RxCUI: 1807888 - metFORMIN HCl 1000 MG Modified 24HR Extended Release Oral Tablet
  • RxCUI: 1807888 - Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet
  • RxCUI: 1807888 - metformin HCl 1000 MG Modified 24 HR Extended Release Oral Tablet
  • RxCUI: 1807915 - metFORMIN HCl 500 MG Modified 24HR Extended Release Oral Tablet
  • RxCUI: 1807915 - Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Glumetza
Non-Proprietary Name
Metformin Hydrochloride
Substance Name
Metformin Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METFORMIN HYDROCHLORIDE 1000 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. 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.

Regulatory & Marketing

Labeler Name
Santarus, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021748
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-17-2008
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 (68012-003). Click a package code to view its specific billing and regulatory data.

68012-003-16
90 TABLET, FILM COATED, EXTENDED RELEASE 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 68012-003-97 identifies a specific commercial package of 7 tablet, film coated, extended release in 1 bottle of Glumetza, a human prescription drug labeled by Santarus, Inc.. This tablet, film coated, 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 Santarus, Inc. on June 17, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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. 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.

How is this Santarus, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68012000397. 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)
68012-003-97
11-Digit CMS (5-4-2)
68012-0003-97

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