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  5. NDC Package Code: 53808-1066-1 Amiodarone Hydrochloride

NDC Package 53808-1066-1 Amiodarone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
53808-1066-1
Package Description:
30 TABLET in 1 BLISTER PACK
Product Code:
53808-1066
Proprietary Name:
Amiodarone Hydrochloride
Usage Information:
Because of its life-threatening side effects and the substantial management difficulties associated with its use (see WARNINGS below), amiodarone is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.Recurrent ventricular fibrillation.Recurrent hemodynamically unstable ventricular tachycardia.As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival.Amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy, and potential exacerbation of the arrhythmia, initiation of therapy with amiodarone should be carried out in the hospital.
11-Digit NDC Billing Format:
53808106601
NDC to RxNorm Crosswalk:
  • RxCUI: 833528 - amiodarone HCl 200 MG Oral Tablet
  • RxCUI: 833528 - amiodarone hydrochloride 200 MG Oral Tablet
    • Labeler Name:
    State Of Florida Doh Central Pharmacy
    Sample Package:
    No
    Start Marketing Date:
    11-01-2014
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    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 53808-1066-1?

    The NDC Packaged Code 53808-1066-1 is assigned to a package of 30 tablet in 1 blister pack of Amiodarone Hydrochloride, labeled by State Of Florida Doh Central Pharmacy. The product's dosage form is and is administered via form.

    Is NDC 53808-1066 included in the NDC Directory?

    No, Amiodarone Hydrochloride with product code 53808-1066 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by State Of Florida Doh Central Pharmacy on November 01, 2014 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53808-1066-1?

    The 11-digit format is 53808106601. 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
    5-4-153808-1066-15-4-253808-1066-01