1. Home
  2. Labeler Index
  3. Janssen Cilag Spa
  4. 62579-301
  5. NDC Package Code: 62579-301-00 Dimethyl Fumarate

NDC Package 62579-301-00 Dimethyl Fumarate

Capsule, Gelatin 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:
62579-301-00
Package Description:
16000 CAPSULE, GELATIN COATED in 1 DRUM
Product Code:
62579-301
Non-Proprietary Name:
Dimethyl Fumarate
Substance Name:
Dimethyl Fumarate
Usage Information:
Dimethyl fumarate is used to treat multiple sclerosis (MS). It is not a cure for MS. It helps decrease the number of episodes of worsening MS.
11-Digit NDC Billing Format:
62579030100
Product Type:
Drug For Further Processing
Labeler Name:
Janssen Cilag Spa
Dosage Form:
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Active Ingredient(s):
  • DIMETHYL FUMARATE 240 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:
    03-27-2013
    Listing Expiration Date:
    12-31-2025
    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 62579-301-00?

    The NDC Packaged Code 62579-301-00 is assigned to an UNFINISHED drug package of 16000 capsule, gelatin coated in 1 drum of Dimethyl Fumarate, drug for further processing labeled by Janssen Cilag Spa. The product's dosage form is capsule, gelatin coated and is administered via form.

    Is NDC 62579-301 included in the NDC Directory?

    Yes, Dimethyl Fumarate is an UNFINISHED PRODUCT with code 62579-301 that is active and included in the NDC Directory. The product was first marketed by Janssen Cilag Spa on March 27, 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 62579-301-00?

    The 11-digit format is 62579030100. 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
    5-3-262579-301-005-4-262579-0301-00