Flecainide Acetate Tablet
NDC Package 0054-0010-25

11-digit billing NDC: 00054001025 · Billing unit: EA · 100 EA per package
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 acetate 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 symptomsFlecainide acetate 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 acetate for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. This formulation utilizes a tablet delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-0010 and is authorized under FDA application ANDA076278.

Identification & Billing

NDC Package Code
0054-0010-25
Package Description
100 TABLET in 1 BOTTLE
Product Code
0054-0010
11-Digit Billing Format
00054001025
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
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 acetate 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 symptomsFlecainide acetate 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 acetate for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.Because of the proarrhythmic effects of flecainide acetate tablets, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.Flecainide acetate should not be used in patients with recent myocardial infarction. (See Boxed WARNINGS.)Use of flecainide acetate 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 acetate favorably affects survival or the incidence of sudden death.

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076278
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-14-2003
Listing Expiration
12-31-2026
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 (0054-0010). Click a package code to view its specific billing and regulatory data.

0054-0010-20
100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
0054-0010-21
60 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 0054-0010-25 identifies a specific commercial package of 100 tablet in 1 bottle of Flecainide Acetate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. 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 Hikma Pharmaceuticals Usa Inc. on January 14, 2003. The current certification is valid through December 31, 2026.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054001025. 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)
0054-0010-25
11-Digit CMS (5-4-2)
00054-0010-25

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