Flecainide Acetate Powder
NDC Package 57741-0800-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Flecainide Acetate powders is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular tachycardia and paroxysmal supraventricular tachycardia). This formulation utilizes a powder delivery system. Marketed by Maprimed S.a., this product is identified by NDC 57741-0800.

Identification & Billing

NDC Package Code
57741-0800-0
Package Description
25 kg in 1 DRUM
Product Code
57741-0800
11-Digit Billing Format
57741080000

Clinical Specifications

Proprietary Name
Flecainide Acetate
Non-Proprietary Name
Flecainide Acetate
Substance Name
Flecainide Acetate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
FLECAINIDE ACETATE 1 kg/kg
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
Maprimed S.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-31-1985
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 57741-0800-0 identifies a specific commercial package of 25 kg in 1 drum of Flecainide Acetate (UNFINISHED drug), a bulk ingredient labeled by Maprimed S.a.. This powder is formulated for 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 Maprimed S.a. on October 31, 1985. The current certification is valid through December 31, 2026.

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 Maprimed S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57741080000. 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)
57741-0800-0
11-Digit CMS (5-4-2)
57741-0800-00

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