1. Home
  2. Labeler Index
  3. Genzyme Corporation
  4. 58468-0211
  5. NDC Package Code: 58468-0211-2 Aubagio

NDC Package 58468-0211-2 Aubagio

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
58468-0211-2
Package Description:
1 BLISTER PACK in 1 CARTON / 5 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
58468-0211
Proprietary Name:
Aubagio
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:
58468021102
NDC to RxNorm Crosswalk:
  • RxCUI: 1310525 - teriflunomide 14 MG Oral Tablet
  • RxCUI: 1310531 - Aubagio 14 MG Oral Tablet
  • RxCUI: 1310531 - teriflunomide 14 MG Oral Tablet [Aubagio]
  • RxCUI: 1310533 - teriflunomide 7 MG Oral Tablet
  • RxCUI: 1310535 - Aubagio 7 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genzyme Corporation
    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):
  • TERIFLUNOMIDE 7 mg/1
    • Pharmacologic Class(es):
  • Dihydroorotate Dehydrogenase Inhibitors - [MoA] (Mechanism of Action)
  • Pyrimidine Synthesis Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA202992
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-01-2013
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58468-0211-31 BLISTER PACK in 1 CARTON / 5 TABLET, FILM COATED in 1 BLISTER PACK
    58468-0211-41 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58468-0211-2?

    The NDC Packaged Code 58468-0211-2 is assigned to a package of 1 blister pack in 1 carton / 5 tablet, film coated in 1 blister pack of Aubagio, a human prescription drug labeled by Genzyme Corporation. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 58468-0211 included in the NDC Directory?

    Yes, Aubagio with product code 58468-0211 is active and included in the NDC Directory. The product was first marketed by Genzyme Corporation on May 01, 2013 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 11-digit format for NDC 58468-0211-2?

    The 11-digit format is 58468021102. 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
    5-4-158468-0211-25-4-258468-0211-02