Amiodarone Hcl
NDC Package 42494-308-06

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 discontinued by the firm.

Amiodarone Hcl is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular fibrillation/tachycardia). Marketed by Cameron Pharmaceuticals, Llc, this product is identified by NDC 42494-308 and is authorized under FDA application ANDA077069.

Identification & Billing

NDC Package Code
42494-308-06
Package Description
60 TABLET in 1 BOTTLE
Product Code
42494-308
11-Digit Billing Format
42494030806

Clinical Specifications

Proprietary Name
Amiodarone Hcl
Dosage Form
-
Usage Information
This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular fibrillation/tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Amiodarone is known as an anti-arrhythmic drug. It works by blocking certain electrical signals in the heart that can cause an irregular heartbeat.

Regulatory & Marketing

Labeler Name
Cameron Pharmaceuticals, Llc
FDA Application #
ANDA077069
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2013
End Marketing Date
08-12-2022
Listing Expiration
08-12-2022
Exclude Flag
D
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 42494-308-06 identifies a specific commercial package of 60 tablet in 1 bottle of Amiodarone Hcl, labeled by Cameron Pharmaceuticals, Llc. 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 Cameron Pharmaceuticals, Llc on January 01, 2013. The current certification is valid through August 12, 2022.

What are the primary indications for this medication?

This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular fibrillation/tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Amiodarone is known as an anti-arrhythmic drug. It works by blocking certain electrical signals in the heart that can cause an irregular heartbeat.

How is this Cameron Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42494030806. 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)
42494-308-06
11-Digit CMS (5-4-2)
42494-0308-06

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