1. Home
  2. Labeler Index
  3. Glenmark Pharmaceuticals Inc., Usa
  4. 68462-570
  5. NDC Package Code: 68462-570-78 Dimethyl Fumarate

NDC Package 68462-570-78 Dimethyl Fumarate

Dimethyl Fumarate Kit Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
68462-570-78
Package Description:
1 KIT in 1 KIT * 46 CAPSULE in 1 BOTTLE * 14 CAPSULE in 1 BOTTLE
Product Code:
68462-570
Proprietary Name:
Dimethyl Fumarate
Non-Proprietary Name:
Dimethyl Fumarate Kit
Usage Information:
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
11-Digit NDC Billing Format:
68462057078
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:
    Glenmark Pharmaceuticals Inc., Usa
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA210309
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-06-2020
    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 68462-570-78?

    The NDC Packaged Code 68462-570-78 is assigned to a package of 1 kit in 1 kit * 46 capsule in 1 bottle * 14 capsule in 1 bottle of Dimethyl Fumarate, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is kit and is administered via form.

    Is NDC 68462-570 included in the NDC Directory?

    Yes, Dimethyl Fumarate with product code 68462-570 is active and included in the NDC Directory. The product was first marketed by Glenmark Pharmaceuticals Inc., Usa on October 06, 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 68462-570-78?

    The 11-digit format is 68462057078. 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
    5-3-268462-570-785-4-268462-0570-78