Metformin Hydrochloride Tablet, Film Coated
NDC Package 71205-784-78

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 Proficient Rx Lp, this product is identified by NDC 71205-784 and is authorized under FDA application ANDA203769.

Identification & Billing

NDC Package Code
71205-784-78
Package Description
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
71205-784
11-Digit Billing Format
71205078478
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
180 EA
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)
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 pediatric patients 10 years of age and older with type 2 diabetes mellitus.

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA203769
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-21-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71205-784). Click a package code to view its specific billing and regulatory data.

71205-784-30
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
71205-784-60
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
71205-784-90
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 71205-784-78 identifies a specific commercial package of 180 tablet, film coated in 1 bottle, plastic of Metformin Hydrochloride, a human prescription drug labeled by Proficient Rx Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 180 billable units per package. 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 Proficient Rx Lp on November 21, 2017. The current certification is valid through December 31, 2026.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71205078478. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 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)
71205-784-78
11-Digit CMS (5-4-2)
71205-0784-78

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