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  5. NDC Package Code: 12579-186-14 Teriflunomide

NDC Package 12579-186-14 Teriflunomide

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:
12579-186-14
Package Description:
14 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
12579-186
Non-Proprietary Name:
Teriflunomide
Substance Name:
Teriflunomide
Usage Information:
This medication is used to treat multiple sclerosis-MS. It is not a cure for MS but is thought to work by decreasing certain immune system cells (lymphocytes) which can attack the nerves in your brain and spinal cord. This helps decrease the number of flare-ups (relapses) and may help slow down physical problems caused by MS.
11-Digit NDC Billing Format:
12579018614
Product Type:
Drug For Further Processing
Labeler Name:
Opella Healthcare International Sas
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):
  • TERIFLUNOMIDE 14 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:
    09-13-2012
    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
    12579-186-055 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 12579-186-14?

    The NDC Packaged Code 12579-186-14 is assigned to an UNFINISHED drug package of 14 tablet, film coated in 1 blister pack of Teriflunomide, drug for further processing labeled by Opella Healthcare International Sas. The product's dosage form is tablet, film coated and is administered via form.

    Is NDC 12579-186 included in the NDC Directory?

    Yes, Teriflunomide is an UNFINISHED PRODUCT with code 12579-186 that is active and included in the NDC Directory. The product was first marketed by Opella Healthcare International Sas on September 13, 2012 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 12579-186-14?

    The 11-digit format is 12579018614. 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
    5-3-212579-186-145-4-212579-0186-14