Amiodarone Hydrochloride Tablet
NDC Package 55154-3365-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Amiodarone Hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. This formulation utilizes a tablet delivery system. Marketed by Cardinal Health 107, Llc, this product is identified by NDC 55154-3365 and is authorized under FDA application ANDA075424.

Identification & Billing

NDC Package Code
55154-3365-0
Package Description
10 BLISTER PACK in 1 BAG / 1 TABLET in 1 BLISTER PACK
Product Code
55154-3365
11-Digit Billing Format
55154336500
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
Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated.

Regulatory & Marketing

Labeler Name
Cardinal Health 107, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075424
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-30-2001
End Marketing Date
01-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55154-3365-0 identifies a specific commercial package of 10 blister pack in 1 bag / 1 tablet in 1 blister pack of Amiodarone Hydrochloride, a human prescription drug labeled by Cardinal Health 107, Llc. 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 Cardinal Health 107, Llc on March 30, 2001.

How is this Cardinal Health 107, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55154336500. 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)
55154-3365-0
11-Digit CMS (5-4-2)
55154-3365-00

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