Metformin Hydrochloride
NDC Package 48433-326-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Metformin Hydrochloride is tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Marketed by Safecor Health, Llc, this product is identified by NDC 48433-326 and is authorized under FDA application ANDA075978.

Identification & Billing

NDC Package Code
48433-326-10
Package Description
100 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 POUCH (48433-326-01)
Product Code
48433-326
11-Digit Billing Format
48433032610
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
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Safecor Health, Llc
FDA Application #
ANDA075978
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2014
Listing Expiration
12-31-2017
Exclude Flag
I
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 48433-326-10 identifies a specific commercial package of 100 pouch in 1 box, unit-dose / 1 tablet, film coated in 1 pouch (48433-326-01) of Metformin Hydrochloride, labeled by Safecor Health, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Safecor Health, Llc on September 30, 2014. The current certification is valid through December 31, 2017.

How is this Safecor Health, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48433032610. 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)
48433-326-10
11-Digit CMS (5-4-2)
48433-0326-10

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