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  5. NDC Package Code: 60505-3615-4 Varenicline

NDC Package 60505-3615-4 Varenicline

Kit 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:
60505-3615-4
Package Description:
1 KIT in 1 CARTON * 11 TABLET, FILM COATED in 1 BLISTER PACK (60505-3606-1) * 42 TABLET, FILM COATED in 1 BLISTER PACK (60505-3607-1)
Product Code:
60505-3615
Proprietary Name:
Varenicline
Non-Proprietary Name:
Varenicline
Usage Information:
Varenicline tablets are indicated for use as an aid to smoking cessation treatment.
11-Digit NDC Billing Format:
60505361504
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
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:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Sample Package:
    No
    FDA Application Number:
    ANDA201962
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-15-2024
    Listing Expiration Date:
    12-31-2025
    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 60505-3615-4?

    The NDC Packaged Code 60505-3615-4 is assigned to a package of 1 kit in 1 carton * 11 tablet, film coated in 1 blister pack (60505-3606-1) * 42 tablet, film coated in 1 blister pack (60505-3607-1) of Varenicline, a human prescription drug labeled by Apotex Corp. The product's dosage form is kit and is administered via oral form.

    Is NDC 60505-3615 included in the NDC Directory?

    Yes, Varenicline with product code 60505-3615 is active and included in the NDC Directory. The product was first marketed by Apotex Corp on January 15, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 60505-3615-4?

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

    What is the 11-digit format for NDC 60505-3615-4?

    The 11-digit format is 60505361504. 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
    5-4-160505-3615-45-4-260505-3615-04