Flecainide Acetate
NDC Package 42291-293-01

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.

Flecainide Acetate is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular tachycardia and paroxysmal supraventricular tachycardia). Marketed by Avkare, Inc., this product is identified by NDC 42291-293 and is authorized under FDA application ANDA075442.

Identification & Billing

NDC Package Code
42291-293-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
42291-293
11-Digit Billing Format
42291029301

Clinical Specifications

Proprietary Name
Flecainide Acetate
Dosage Form
-
Usage Information
This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular tachycardia and paroxysmal supraventricular tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. It is also used to prevent certain types of irregular heartbeat from returning (such as atrial fibrillation). Flecainide is known as an anti-arrhythmic drug. It works by blocking 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. Older adults should discuss the risks and benefits of this medication with their doctor or pharmacist, as well as other effective and possibly safer treatments.

Regulatory & Marketing

Labeler Name
Avkare, Inc.
FDA Application #
ANDA075442
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-22-2016
End Marketing Date
10-31-2020
Listing Expiration
10-31-2020
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 42291-293-01 identifies a specific commercial package of 100 tablet in 1 bottle of Flecainide Acetate, labeled by Avkare, 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 Avkare, Inc. on June 22, 2016. The current certification is valid through October 31, 2020.

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 tachycardia and paroxysmal supraventricular tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. It is also used to prevent certain types of irregular heartbeat from returning (such as atrial fibrillation). Flecainide is known as an anti-arrhythmic drug. It works by blocking 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. Older adults should discuss the risks and benefits of this medication with their doctor or pharmacist, as well as other effective and possibly safer treatments.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291029301. 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)
42291-293-01
11-Digit CMS (5-4-2)
42291-0293-01

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