Dimethyl Fumarate Kit
NDC Package 69097-552-03

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

Package Information

Dimethyl Fumarate kits is dimethyl fumarate is used to treat multiple sclerosis (MS). This formulation utilizes a kit delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-552 and is authorized under FDA application ANDA210305.

Identification & Billing

NDC Package Code
69097-552-03
Package Description
1 KIT in 1 KIT * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code
69097-552
11-Digit Billing Format
69097055203
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
Dosage Form
Kit - A packaged collection of related material.
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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210305
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-24-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 69097-552-03 identifies a specific commercial package of 1 kit in 1 kit * 14 capsule, delayed release in 1 bottle, plastic * 46 capsule, delayed release in 1 bottle, plastic of Dimethyl Fumarate, a human prescription drug labeled by Cipla Usa Inc.. This kit is formulated for use and contains 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 Cipla Usa Inc. on September 24, 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 Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097055203. 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)
69097-552-03
11-Digit CMS (5-4-2)
69097-0552-03

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