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  5. NDC Package Code: 53360-4142-1 Dronedarone

NDC Package 53360-4142-1 Dronedarone

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
53360-4142-1
Package Description:
50 BLISTER PACK in 1 BOX / 6 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
53360-4142
Non-Proprietary Name:
Dronedarone
Substance Name:
Dronedarone
11-Digit NDC Billing Format:
53360414201
Product Type:
Drug For Further Processing
Labeler Name:
Sanofi Winthrop Industrie
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):
  • DRONEDARONE 400 mg/1
  • DRONEDARONE 400 mg/1
    • 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:
    07-01-2009
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53360-4142-650 BLISTER PACK in 1 BOX / 6 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53360-4142-1?

    The NDC Packaged Code 53360-4142-1 is assigned to an UNFINISHED drug package of 50 blister pack in 1 box / 6 tablet, film coated in 1 blister pack of Dronedarone, drug for further processing labeled by Sanofi Winthrop Industrie. The product's dosage form is tablet, film coated and is administered via form.

    Is NDC 53360-4142 included in the NDC Directory?

    Yes, Dronedarone is an UNFINISHED PRODUCT with code 53360-4142 that is active and included in the NDC Directory. The product was first marketed by Sanofi Winthrop Industrie on July 01, 2009 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 53360-4142-1?

    The 11-digit format is 53360414201. 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
    5-4-153360-4142-15-4-253360-4142-01