Varenicline Powder
NDC Package 70600-015-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 powders is varenicline is used by adults to help stop smoking. This formulation utilizes a powder delivery system. Marketed by Maithri Drugs Private Limited, this product is identified by NDC 70600-015.

Identification & Billing

NDC Package Code
70600-015-01
Package Description
50 kg in 1 PACKAGE
Product Code
70600-015
11-Digit Billing Format
70600001501

Clinical Specifications

Proprietary Name
Varenicline
Non-Proprietary Name
Varenicline
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
Maithri Drugs Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-23-2019
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70600-015-01 identifies a specific commercial package of 50 kg in 1 package of Varenicline (UNFINISHED drug), a bulk ingredient labeled by Maithri Drugs Private Limited. 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 Maithri Drugs Private Limited on August 23, 2019. The current certification is valid through December 31, 2026.

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 Maithri Drugs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70600001501. 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)
70600-015-01
11-Digit CMS (5-4-2)
70600-0015-01

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