Varenicline Tartrate Powder
NDC Package 75945-040-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Varenicline Tartrate powders is varenicline is used by adults to help stop smoking. This formulation utilizes a powder delivery system. Marketed by Lee Pharma Ltd., this product is identified by NDC 75945-040.

Identification & Billing

NDC Package Code
75945-040-01
Package Description
1 kg in 1 DRUM
Product Code
75945-040
11-Digit Billing Format
75945004001

Clinical Specifications

Proprietary Name
Varenicline Tartrate
Non-Proprietary Name
Varenicline Tartrate
Substance Name
Varenicline Tartrate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
VARENICLINE TARTRATE 1 kg/kg
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
Lee Pharma Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-01-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (75945-040). Click a package code to view its specific billing and regulatory data.

75945-040-11
11.5 kg in 1 DRUM
75945-040-57
5.7 kg in 1 DRUM

* 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 75945-040-01 identifies a specific commercial package of 1 kg in 1 drum of Varenicline Tartrate (UNFINISHED drug), a bulk ingredient labeled by Lee Pharma Ltd.. This powder is formulated for 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 Lee Pharma Ltd. on April 01, 2021. 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 Lee Pharma Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75945004001. 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)
75945-040-01
11-Digit CMS (5-4-2)
75945-0040-01

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