Multaq Tablet, Film Coated
NDC Package 0024-4142-06

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

Multaq (dronedarone) tablets is a medication used if you have had certain types of irregular heartbeat (paroxysmal or persistent atrial fibrillation) in the past but now have a normal heart rhythm. This formulation utilizes a tablet, film coated delivery system. Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0024-4142 and is authorized under FDA application NDA022425.

Identification & Billing

NDC Package Code
0024-4142-06
Package Description
8 BLISTER PACK in 1 BOX / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)
Product Code
0024-4142
11-Digit Billing Format
00024414206
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Multaq
Non-Proprietary Name
Dronedarone
Substance Name
Dronedarone
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DRONEDARONE 400 mg/1
Pharmacologic Class
Usage Information
This medication is used if you have had certain types of irregular heartbeat (paroxysmal or persistent atrial fibrillation) in the past but now have a normal heart rhythm. It helps you keep a normal heart rhythm and lowers your chance of having to go to the hospital for atrial fibrillation. Dronedarone is known as an antiarrhythmic drug. This medication should not be used if you have permanent atrial fibrillation because of the increased risk of very serious side effects. See also Warning section.

Regulatory & Marketing

Labeler Name
Sanofi-aventis U.s. Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022425
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2009
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 (0024-4142). Click a package code to view its specific billing and regulatory data.

0024-4142-00
6 TABLET, FILM COATED in 1 BLISTER PACK
0024-4142-10
10 BLISTER PACK in 1 BOX / 10 TABLET, FILM COATED in 1 BLISTER PACK
0024-4142-50
500 TABLET, FILM COATED in 1 BOTTLE
0024-4142-60
60 TABLET, FILM COATED 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 0024-4142-06 identifies a specific commercial package of 8 blister pack in 1 box / 6 tablet, film coated in 1 blister pack (0024-4142-00) of Multaq, a human prescription drug labeled by Sanofi-aventis U.s. Llc. This tablet, film coated is formulated for oral use and contains dronedarone 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 Sanofi-aventis U.s. Llc on July 01, 2009. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used if you have had certain types of irregular heartbeat (paroxysmal or persistent atrial fibrillation) in the past but now have a normal heart rhythm. It helps you keep a normal heart rhythm and lowers your chance of having to go to the hospital for atrial fibrillation. Dronedarone is known as an antiarrhythmic drug. This medication should not be used if you have permanent atrial fibrillation because of the increased risk of very serious side effects. See also Warning section.

How is this Sanofi-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00024414206. 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 (4-4-2)
0024-4142-06
11-Digit CMS (5-4-2)
00024-4142-06

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