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  5. NDC Package Code: 60505-4765-5 Apo-varenicline

NDC Package 60505-4765-5 Apo-varenicline

Varenicline 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:
60505-4765-5
Package Description:
56 TABLET, FILM COATED in 1 BOTTLE
Product Code:
60505-4765
Proprietary Name:
Apo-varenicline
Non-Proprietary Name:
Varenicline
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:
60505476505
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
56 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Apotex Corp
    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 .5 mg/1
    • Pharmacologic Class(es):
  • Cholinergic Agonists - [MoA] (Mechanism of Action)
  • Cholinergic Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Partial Cholinergic Nicotinic Agonist - [EPC] (Established Pharmacologic Class)
  • Partial Cholinergic Nicotinic Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE -
    Start Marketing Date:
    07-16-2021
    End Marketing Date:
    03-31-2025
    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 60505-4765-5?

    The NDC Packaged Code 60505-4765-5 is assigned to a package of 56 tablet, film coated in 1 bottle of Apo-varenicline, a human prescription drug labeled by Apotex Corp. 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 56 billable units per package.

    Is NDC 60505-4765 included in the NDC Directory?

    Yes, Apo-varenicline with product code 60505-4765 is active and included in the NDC Directory. The product was first marketed by Apotex Corp on July 16, 2021.

    What is the NDC billing unit for package 60505-4765-5?

    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 56.

    What is the 11-digit format for NDC 60505-4765-5?

    The 11-digit format is 60505476505. 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 5-4-1 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
    5-4-160505-4765-55-4-260505-4765-05