NDC Package 69097-323-03 Dimethyl Fumarate

Capsule, Delayed Release 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:
69097-323-03
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Dimethyl Fumarate
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:
69097032303
NDC to 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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Cipla Usa Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA210305
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-24-2020
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 69097-323-03?

    The NDC Packaged Code 69097-323-03 is assigned to a package of 1 bottle, plastic in 1 carton / 60 capsule, delayed release in 1 bottle, plastic of Dimethyl Fumarate, a human prescription drug labeled by Cipla Usa Inc.. The product's dosage form is capsule, delayed release and is administered via oral form.

    Is NDC 69097-323 included in the NDC Directory?

    Yes, Dimethyl Fumarate with product code 69097-323 is active and included in the NDC Directory. The product was first marketed by Cipla Usa Inc. on September 24, 2020 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 69097-323-03?

    The 11-digit format is 69097032303. 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
    5-3-269097-323-035-4-269097-0323-03