Dimethyl Fumarate Capsule, Delayed Release
NDC Package 70710-1205-8

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Dimethyl Fumarate capsules is dimethyl fumarate is used to treat multiple sclerosis (MS). This formulation utilizes a capsule, delayed release delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-1205 and is authorized under FDA application ANDA210538.

Identification & Billing

NDC Package Code
70710-1205-8
Package Description
46 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
70710-1205
11-Digit Billing Format
70710120508
RxNorm Crosswalk
  • RxCUI: 1373483 - dimethyl fumarate 120 MG Delayed Release Oral Capsule
  • RxCUI: 1373491 - dimethyl fumarate 240 MG Delayed Release Oral Capsule
  • RxCUI: 1373497 - {14 (dimethyl fumarate 120 MG Delayed Release Oral Capsule) / 46 (dimethyl fumarate 240 MG Delayed Release Oral Capsule) } Pack
  • RxCUI: 1373497 - dimethyl fumarate starter dose 120 MG (14), 240 MG (46) Delayed Release Oral Capsule 60 Count Pack

Clinical Specifications

Proprietary Name
Dimethyl Fumarate
Non-Proprietary Name
Dimethyl Fumarate
Substance Name
Dimethyl Fumarate
Dosage Form
Capsule, Delayed Release - 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, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
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
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210538
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-28-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70710-1205). Click a package code to view its specific billing and regulatory data.

70710-1205-6
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE

* 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 70710-1205-8 identifies a specific commercial package of 46 capsule, delayed release in 1 bottle of Dimethyl Fumarate, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This capsule, delayed release is formulated for oral 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 Zydus Pharmaceuticals Usa Inc. on September 28, 2020. 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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710120508. 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 (5-4-1)
70710-1205-8
11-Digit CMS (5-4-2)
70710-1205-08

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