Metformin Hydrochloride
NDC Package 65841-030-16

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

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

Metformin Hydrochloride is tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Marketed by Cadila Healthcare Limited, this product is identified by NDC 65841-030 and is authorized under FDA application ANDA077064.

Identification & Billing

NDC Package Code
65841-030-16
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
65841-030
11-Digit Billing Format
65841003016
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metformin Hydrochloride
Dosage Form
-
Usage Information
Metformin hydrochloride tablet is 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 tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Cadila Healthcare Limited
FDA Application #
ANDA077064
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2010
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65841-030). Click a package code to view its specific billing and regulatory data.

65841-030-01
100 TABLET, FILM COATED in 1 BOTTLE
65841-030-05
500 TABLET, FILM COATED in 1 BOTTLE
65841-030-10
1000 TABLET, FILM COATED in 1 BOTTLE
65841-030-61
10 BAG in 1 DRUM / 1000 TABLET, FILM COATED in 1 BAG
65841-030-77
100 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK (65841-030-30)

* 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 65841-030-16 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Metformin Hydrochloride, labeled by Cadila Healthcare Limited. 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 Cadila Healthcare Limited on March 20, 2010. The current certification is valid through December 31, 2024.

How is this Cadila Healthcare Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65841003016. 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)
65841-030-16
11-Digit CMS (5-4-2)
65841-0030-16

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