Propafenone Hydrochloride
NDC Package 54868-5950-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Propafenone Hydrochloride is in patients without structural heart disease, propafenone is indicated to prolong the time to recurrence of–paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.–paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms.As with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5950 and is authorized under FDA application ANDA075998.

Identification & Billing

NDC Package Code
54868-5950-2
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
54868-5950
11-Digit Billing Format
54868595002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Propafenone Hydrochloride
Dosage Form
-
Usage Information
In patients without structural heart disease, propafenone is indicated to prolong the time to recurrence of–paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.–paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms.As with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional AV refractory period is recommended.The use of propafenone HCl in patients with chronic atrial fibrillation has not been evaluated. Propafenone HCl should not be used to control ventricular rate during atrial fibrillation.Propafenone HCl is also indicated for the treatment of–documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of propafenone HCl, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks.Initiation of propafenone HCl treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital.Propafenone HCl, like other antiarrhythmic drugs, has not been shown to enhance survival in patients with ventricular or atrial arrhythmias.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA075998
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-09-2008
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-5950). Click a package code to view its specific billing and regulatory data.

54868-5950-0
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
54868-5950-1
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 54868-5950-2 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Propafenone Hydrochloride, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on October 09, 2008. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868595002. 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)
54868-5950-2
11-Digit CMS (5-4-2)
54868-5950-02

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