NDC Package 0078-0979-92 Mayzent

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

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:
0078-0979-92
Package Description:
28 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Mayzent
Non-Proprietary Name:
Siponimod
Substance Name:
Siponimod
Usage Information:
This medication is used to treat a certain type of multiple sclerosis (relapsing multiple sclerosis-MS). Siponimod is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of disease worsening (relapses) and may prevent or delay disability.
11-Digit NDC Billing Format:
00078097992
NDC to RxNorm Crosswalk:
  • RxCUI: 2121090 - siponimod 0.25 MG Oral Tablet
  • RxCUI: 2121096 - MAYZENT 0.25 MG Oral Tablet
  • RxCUI: 2121096 - siponimod 0.25 MG Oral Tablet [Mayzent]
  • RxCUI: 2121096 - Mayzent 0.25 MG Oral Tablet
  • RxCUI: 2121098 - siponimod 2 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals 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):
    Sample Package:
    Yes
    FDA Application Number:
    NDA209884
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-26-2019
    Listing Expiration Date:
    12-31-2024
    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
    0078-0979-1212 TABLET, FILM COATED in 1 BLISTER PACK
    0078-0979-5028 TABLET, FILM COATED in 1 BOTTLE
    0078-0979-897 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0078-0979-92?

    The NDC Packaged Code 0078-0979-92 is assigned to a package of 28 tablet, film coated in 1 bottle of Mayzent, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0078-0979 included in the NDC Directory?

    Yes, Mayzent with product code 0078-0979 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on March 26, 2019 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 0078-0979-92?

    The 11-digit format is 00078097992. 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 4-4-2 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
    4-4-20078-0979-925-4-200078-0979-92