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  5. NDC Package Code: 10829-1468-1 Varenicline Tartrate

NDC Package 10829-1468-1 Varenicline Tartrate

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
10829-1468-1
Package Description:
1 BAG in 1 BOX / 100 kg in 1 BAG
Product Code:
10829-1468
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:
10829146801
Product Type:
Drug For Further Processing
Labeler Name:
Pfizer Italia S.r.l.
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.
Active Ingredient(s):
  • VARENICLINE TARTRATE 1 kg/kg
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    01-02-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 10829-1468-1?

    The NDC Packaged Code 10829-1468-1 is assigned to an UNFINISHED drug package of 1 bag in 1 box / 100 kg in 1 bag of Varenicline Tartrate, drug for further processing labeled by Pfizer Italia S.r.l.. The product's dosage form is tablet, film coated and is administered via form.

    Is NDC 10829-1468 included in the NDC Directory?

    Yes, Varenicline Tartrate is an UNFINISHED PRODUCT with code 10829-1468 that is active and included in the NDC Directory. The product was first marketed by Pfizer Italia S.r.l. on January 02, 2020 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 11-digit format for NDC 10829-1468-1?

    The 11-digit format is 10829146801. 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
    5-4-110829-1468-15-4-210829-1468-01