Metformin Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 68682-021-50

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 is metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Important Limitations of Use Metformin Hydrochloride Extended-Release Tablets should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-021 and is authorized under FDA application NDA021748.

Identification & Billing

NDC Package Code
68682-021-50
Package Description
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
68682-021
11-Digit Billing Format
68682002150
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
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
Metformin Hydrochloride
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 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 with type 2 diabetes mellitus.Important Limitations of Use Metformin Hydrochloride Extended-Release Tablets should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Regulatory & Marketing

Labeler Name
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA021748
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-20-2018
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 68682-021-50 identifies a specific commercial package of 100 tablet, film coated, extended release in 1 bottle of Metformin Hydrochloride, a human prescription drug labeled by Oceanside Pharmaceuticals. 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 Oceanside Pharmaceuticals on March 20, 2018. The current certification is valid through December 31, 2026.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682002150. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (5-3-2)
68682-021-50
11-Digit CMS (5-4-2)
68682-0021-50

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