Propafenone Hcl Tablet, Film Coated
NDC Package 0591-0582-01

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

Propafenone Hcl (propafenone hydrochloride) tablets is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as paroxysmal supraventricular tachycardia and atrial fibrillation). This formulation utilizes a tablet, film coated delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-0582 and is authorized under FDA application ANDA075203.

Identification & Billing

NDC Package Code
0591-0582-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0591-0582
11-Digit Billing Format
00591058201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Propafenone Hcl
Non-Proprietary Name
Propafenone Hydrochloride
Substance Name
Propafenone Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Antiarrhythmic - [EPC] (Established Pharmacologic Class)
Usage Information
This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as paroxysmal supraventricular tachycardia and atrial fibrillation). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Propafenone is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat. Treating an irregular heartbeat can decrease the risk for blood clots, and this effect can reduce your risk of heart attack or stroke.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075203
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-24-2000
End Marketing Date
06-30-2026
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 (0591-0582). Click a package code to view its specific billing and regulatory data.

0591-0582-00
43000 TABLET, FILM COATED in 1 BAG

* 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 0591-0582-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle, plastic of Propafenone Hcl, a human prescription drug labeled by Actavis Pharma, Inc.. This tablet, film coated is formulated for oral use and contains propafenone 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 Actavis Pharma, Inc. on October 24, 2000.

What are the primary indications for this medication?

This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as paroxysmal supraventricular tachycardia and atrial fibrillation). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Propafenone is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat. Treating an irregular heartbeat can decrease the risk for blood clots, and this effect can reduce your risk of heart attack or stroke.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591058201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (4-4-2)
0591-0582-01
11-Digit CMS (5-4-2)
00591-0582-01

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