Amiodarone Hydrochloride Tablet
NDC Package 65862-732-99

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

Amiodarone Hydrochloride tablets is because of its life-threatening side effects and the substantial management difficulties associated with its use (see “WARNINGS” below), amiodarone hydrochloride tablets are 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 hydrochloride tablets 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. This formulation utilizes a tablet delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-732 and is authorized under FDA application ANDA204742.

Identification & Billing

NDC Package Code
65862-732-99
Package Description
1000 TABLET in 1 BOTTLE
Product Code
65862-732
11-Digit Billing Format
65862073299
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amiodarone Hydrochloride
Non-Proprietary Name
Amiodarone Hydrochloride
Substance Name
Amiodarone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMIODARONE HYDROCHLORIDE 200 mg/1
Pharmacologic Class
Usage Information
Because of its life-threatening side effects and the substantial management difficulties associated with its use (see “WARNINGS” below), amiodarone hydrochloride tablets are 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 hydrochloride tablets 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 hydrochloride tablets should be carried out in the hospital.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204742
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-03-2016
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-732). Click a package code to view its specific billing and regulatory data.

65862-732-01
100 TABLET in 1 BOTTLE
65862-732-05
500 TABLET in 1 BOTTLE
65862-732-25
250 TABLET in 1 BOTTLE
65862-732-30
30 TABLET in 1 BOTTLE
65862-732-60
60 TABLET in 1 BOTTLE
65862-732-90
90 TABLET 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 65862-732-99 identifies a specific commercial package of 1000 tablet in 1 bottle of Amiodarone Hydrochloride, a human prescription drug labeled by Aurobindo Pharma Limited. This tablet is formulated for oral use and contains amiodarone hydrochloride 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 Aurobindo Pharma Limited on June 03, 2016. The current certification is valid through December 31, 2027.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862073299. 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 (5-3-2)
65862-732-99
11-Digit CMS (5-4-2)
65862-0732-99

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