Amiodarone Hydrochloride
NDC Package 53808-1066-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Amiodarone Hydrochloride is 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. Marketed by State Of Florida Doh Central Pharmacy, this product is identified by NDC 53808-1066 and is authorized under FDA application ANDA079029.

Identification & Billing

NDC Package Code
53808-1066-1
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
53808-1066
11-Digit Billing Format
53808106601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amiodarone Hydrochloride
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
State Of Florida Doh Central Pharmacy
FDA Application #
ANDA079029
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2014
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53808-1066-1 identifies a specific commercial package of 30 tablet in 1 blister pack of Amiodarone Hydrochloride, labeled by State Of Florida Doh Central Pharmacy. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by State Of Florida Doh Central Pharmacy on November 01, 2014. The current certification is valid through December 31, 2017.

How is this State Of Florida Doh Central Pharmacy product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53808106601. 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 (5-4-1)
53808-1066-1
11-Digit CMS (5-4-2)
53808-1066-01

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