Varenicline Tablet, Film Coated
NDC Package 0378-5090-73

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Varenicline tablets is varenicline is used by adults to help stop smoking. This formulation utilizes a tablet, film coated delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-5090 and is authorized under FDA application ANDA202019.

Identification & Billing

NDC Package Code
0378-5090-73
Package Description
56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0378-5090
11-Digit Billing Format
00378509073
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
56 EA
RxNorm Crosswalk
  • RxCUI: 636671 - varenicline 0.5 MG Oral Tablet
  • RxCUI: 636671 - varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet
  • RxCUI: 636676 - varenicline 1 MG Oral Tablet
  • RxCUI: 636676 - varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet
  • RxCUI: 749289 - {11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } Pack

Clinical Specifications

Proprietary Name
Varenicline
Non-Proprietary Name
Varenicline
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
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202019
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-14-2024
End Marketing Date
07-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-5090-73 identifies a specific commercial package of 56 tablet, film coated in 1 bottle, plastic of Varenicline, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. 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 Mylan Pharmaceuticals Inc. on March 14, 2024.

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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378509073. 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 (4-4-2)
0378-5090-73
11-Digit CMS (5-4-2)
00378-5090-73

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