Dimethyl Fumarate Capsule, Gelatin Coated
NDC Package 62579-301-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Dimethyl Fumarate capsules is dimethyl fumarate is used to treat multiple sclerosis (MS). This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Janssen Cilag Spa, this product is identified by NDC 62579-301.

Identification & Billing

NDC Package Code
62579-301-00
Package Description
16000 CAPSULE, GELATIN COATED in 1 DRUM
Product Code
62579-301
11-Digit Billing Format
62579030100

Clinical Specifications

Proprietary Name
Dimethyl Fumarate
Non-Proprietary Name
Dimethyl Fumarate
Substance Name
Dimethyl Fumarate
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
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.

Regulatory & Marketing

Labeler Name
Janssen Cilag Spa
Product Type
Drug For Further Processing
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
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62579-301-00 identifies a specific commercial package of 16000 capsule, gelatin coated in 1 drum of Dimethyl Fumarate (UNFINISHED drug), drug for further processing labeled by Janssen Cilag Spa. This capsule, gelatin coated is formulated for use and contains dimethyl fumarate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Janssen Cilag Spa on March 27, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Janssen Cilag Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62579030100. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
62579-301-00
11-Digit CMS (5-4-2)
62579-0301-00

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.