Varenicline Tartrate Kit
NDC Package 42571-475-84

11-digit billing NDC: 42571047584 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Varenicline Tartrate kits is varenicline tablets are indicated for use as an aid to smoking-cessation treatment. This formulation utilizes a kit delivery system. Marketed by Micro Labs Limited, this product is identified by NDC 42571-475 and is authorized under FDA application ANDA218302.

Identification & Billing

NDC Package Code
42571-475-84
Package Description
1 KIT in 1 CARTON * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
42571-475
11-Digit Billing Format
42571047584
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 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 Tartrate
Non-Proprietary Name
Varenicline Tartrate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Varenicline tablets are indicated for use as an aid to smoking-cessation treatment.

Regulatory & Marketing

Labeler Name
Micro Labs Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218302
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2025
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 42571-475-84 identifies a specific commercial package of 1 kit in 1 carton * 11 tablet, film coated in 1 blister pack * 42 tablet, film coated in 1 blister pack of Varenicline Tartrate, a human prescription drug labeled by Micro Labs Limited. This kit is formulated for use and contains 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 Micro Labs Limited on December 01, 2025. The current certification is valid through December 31, 2027.

How is this Micro Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42571047584. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
42571-475-84
11-Digit CMS (5-4-2)
42571-0475-84

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