Metformin Hydrochloride Tablet, Film Coated
NDC Package 65862-009-33

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

Metformin Hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. This formulation utilizes a tablet, film coated delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-009 and is authorized under FDA application ANDA077095.

Identification & Billing

NDC Package Code
65862-009-33
Package Description
300 TABLET, FILM COATED in 1 BOTTLE
Product Code
65862-009
11-Digit Billing Format
65862000933
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Metformin Hydrochloride
Non-Proprietary Name
Metformin Hydrochloride
Substance Name
Metformin Hydrochloride
Dosage Form
Tablet, Film Coated - 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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA077095
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-14-2005
Listing Expiration
12-31-2027
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 (65862-009). Click a package code to view its specific billing and regulatory data.

65862-009-01
100 TABLET, FILM COATED in 1 BOTTLE
65862-009-05
500 TABLET, FILM COATED in 1 BOTTLE
65862-009-15
1500 TABLET, FILM COATED in 1 BAG
65862-009-26
2500 TABLET, FILM COATED in 1 BAG
65862-009-44
2500 TABLET, FILM COATED in 1 BOTTLE
65862-009-50
50 TABLET, FILM COATED in 1 BOTTLE
65862-009-60
60 TABLET, FILM COATED in 1 BOTTLE
65862-009-66
33000 TABLET, FILM COATED in 1 BAG
65862-009-90
90 TABLET, FILM COATED in 1 BOTTLE
65862-009-99
1000 TABLET, FILM COATED 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 65862-009-33 identifies a specific commercial package of 300 tablet, film coated in 1 bottle of Metformin Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. This tablet, film coated 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 Aurobindo Pharma Limited on January 14, 2005. The current certification is valid through December 31, 2027.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862000933. 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)
65862-009-33
11-Digit CMS (5-4-2)
65862-0009-33

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