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  5. NDC Package Code: 43353-899-05 Chantix

NDC Package 43353-899-05 Chantix

Varenicline Tartrate Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43353-899-05
Package Description:
4200 TABLET, FILM COATED in 1 BOTTLE
Product Code:
43353-899
Proprietary Name:
Chantix
Non-Proprietary Name:
Varenicline Tartrate
Substance Name:
Varenicline Tartrate
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.
11-Digit NDC Billing Format:
43353089905
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
4200 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 636676 - varenicline 1 MG Oral Tablet
  • RxCUI: 636676 - varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet
  • RxCUI: 637190 - CHANTIX 1 MG Oral Tablet
  • RxCUI: 637190 - varenicline 1 MG Oral Tablet [Chantix]
  • RxCUI: 637190 - Chantix 1 MG (as varenicline tartrate 1.71 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aphena Pharma Solutions - Tennessee, Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • VARENICLINE TARTRATE 1 mg/1
    • Pharmacologic Class(es):
  • Partial Cholinergic Nicotinic Agonist - [EPC] (Established Pharmacologic Class)
  • Partial Cholinergic Nicotinic Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA021928
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-10-2006
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 43353-899-05?

    The NDC Packaged Code 43353-899-05 is assigned to a package of 4200 tablet, film coated in 1 bottle of Chantix, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 4200 billable units per package.

    Is NDC 43353-899 included in the NDC Directory?

    Yes, Chantix with product code 43353-899 is active and included in the NDC Directory. The product was first marketed by Aphena Pharma Solutions - Tennessee, Llc on May 10, 2006 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 43353-899-05?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 4200.

    What is the 11-digit format for NDC 43353-899-05?

    The 11-digit format is 43353089905. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243353-899-055-4-243353-0899-05