Metformin Hydrochloride Tablet, Extended Release
NDC Package 33342-239-11

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 children with type 2 diabetes mellitus. This formulation utilizes a tablet, extended release delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-239 and is authorized under FDA application ANDA206955.

Identification & Billing

NDC Package Code
33342-239-11
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
33342-239
11-Digit Billing Format
33342023911
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: 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
  • RxCUI: 860981 - metFORMIN HCl 750 MG 24HR Extended Release Oral Tablet
  • RxCUI: 860981 - 24 HR metformin hydrochloride 750 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Metformin Hydrochloride
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 hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. 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.

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA206955
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2016
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 33342-239-11 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Metformin Hydrochloride, a human prescription drug labeled by Macleods Pharmaceuticals Limited. 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 Macleods Pharmaceuticals Limited on December 08, 2016. The current certification is valid through December 31, 2026.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342023911. 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)
33342-239-11
11-Digit CMS (5-4-2)
33342-0239-11

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