Flecainide Acetate Tablet
NDC Package 53746-641-10

11-digit billing NDC: 53746064110
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Flecainide Acetate tablets is in patients without structural heart disease, flecainide is indicated for the prevention of -     paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms  -     paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. This formulation utilizes a tablet delivery system. Marketed by Amneal Pharmaceuticals Of New York Llc, this product is identified by NDC 53746-641 and is authorized under FDA application ANDA075442.

Identification & Billing

NDC Package Code
53746-641-10
Package Description
1000 TABLET in 1 BOTTLE
Product Code
53746-641
11-Digit Billing Format
53746064110
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Flecainide Acetate
Non-Proprietary Name
Flecainide Acetate
Substance Name
Flecainide Acetate
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)
FLECAINIDE ACETATE 50 mg/1
Pharmacologic Class
Antiarrhythmic - [EPC] (Established Pharmacologic Class)
Usage Information
In patients without structural heart disease, flecainide is indicated for the prevention of -     paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms  -     paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. Flecainide is also indicated for the prevention of -     documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician, are life-threatening. Use of flecainide for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide should not be used in patients with recent myocardial infarction (see Boxed WARNINGS).Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended (see Boxed WARNINGS).As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide favorably affects survival or the incidence of sudden death.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Of New York Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075442
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2009
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 (53746-641). Click a package code to view its specific billing and regulatory data.

53746-641-01
100 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 53746-641-10 identifies a specific commercial package of 1000 tablet in 1 bottle of Flecainide Acetate, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. This tablet is formulated for oral use and contains flecainide acetate 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 Amneal Pharmaceuticals Of New York Llc on December 01, 2009. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Of New York Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53746064110. 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)
53746-641-10
11-Digit CMS (5-4-2)
53746-0641-10

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