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  5. NDC Package Code: 55154-8104-2 Multaq

NDC Package 55154-8104-2 Multaq

Dronedarone Tablet, Film Coated Oral - 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:
55154-8104-2
Package Description:
1260 TABLET, FILM COATED in 1 BOTTLE
Product Code:
55154-8104
Proprietary Name:
Multaq
Non-Proprietary Name:
Dronedarone
Substance Name:
Dronedarone
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.
11-Digit NDC Billing Format:
55154810402
NDC to RxNorm Crosswalk:
  • RxCUI: 854856 - dronedarone 400 MG Oral Tablet
  • RxCUI: 854856 - dronedarone (as dronedarone hydrochloride) 400 MG Oral Tablet
  • RxCUI: 854859 - MULTAQ 400 MG Oral Tablet
  • RxCUI: 854859 - dronedarone 400 MG Oral Tablet [Multaq]
  • RxCUI: 854859 - Multaq 400 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Cardinal Health 107, Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DRONEDARONE 400 mg/1
    • Pharmacologic Class(es):
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA022425
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-01-2009
    Listing Expiration Date:
    12-31-2024
    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 55154-8104-2?

    The NDC Packaged Code 55154-8104-2 is assigned to a package of 1260 tablet, film coated in 1 bottle of Multaq, a human prescription drug labeled by Cardinal Health 107, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 55154-8104 included in the NDC Directory?

    Yes, Multaq with product code 55154-8104 is active and included in the NDC Directory. The product was first marketed by Cardinal Health 107, Llc on July 01, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 55154-8104-2?

    The 11-digit format is 55154810402. 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 5-4-1 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
    5-4-155154-8104-25-4-255154-8104-02