Varenicline Tablet, Film Coated
NDC Package 10135-809-56

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

Package Information

Varenicline (varenicline tartrate) tablets is varenicline is used by adults to help stop smoking. This formulation utilizes a tablet, film coated delivery system. Marketed by Marlex Pharmaceuticals, Inc., this product is identified by NDC 10135-809 and is authorized under FDA application ANDA217283.

Identification & Billing

NDC Package Code
10135-809-56
Package Description
56 TABLET, FILM COATED in 1 BOTTLE
Product Code
10135-809
11-Digit Billing Format
10135080956
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
56 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Varenicline
Non-Proprietary Name
Varenicline Tartrate
Substance Name
Varenicline Tartrate
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)
VARENICLINE TARTRATE 1 mg/1
Pharmacologic Class
Usage Information
Varenicline is used by adults to help stop smoking. To increase your chance of success, use this medication with a stop-smoking program that includes education, support, and counseling. Quitting smoking lowers your risk of heart and lung disease, as well as cancer. Varenicline works by blocking nicotine's effects in the brain that make you want to smoke. Discuss the risks and benefits of this medication, as well as other ways to quit smoking (such as nicotine replacement treatment), with your doctor.

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217283
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10135-809-56 identifies a specific commercial package of 56 tablet, film coated in 1 bottle of Varenicline, a human prescription drug labeled by Marlex Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 56 billable units per package. This tablet, film coated is formulated for oral use and contains varenicline tartrate 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 Marlex Pharmaceuticals, Inc. on January 01, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Varenicline is used by adults to help stop smoking. To increase your chance of success, use this medication with a stop-smoking program that includes education, support, and counseling. Quitting smoking lowers your risk of heart and lung disease, as well as cancer. Varenicline works by blocking nicotine's effects in the brain that make you want to smoke. Discuss the risks and benefits of this medication, as well as other ways to quit smoking (such as nicotine replacement treatment), with your doctor.

How is this Marlex Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135080956. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 56 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)
10135-809-56
11-Digit CMS (5-4-2)
10135-0809-56

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