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  5. NDC Package Code: 0378-8510-01 Flecainide Acetate

NDC Package 0378-8510-01 Flecainide Acetate

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0378-8510-01
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
0378-8510
Proprietary Name:
Flecainide Acetate
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.
11-Digit NDC Billing Format:
00378851001
Labeler Name:
Mylan Pharmaceuticals Inc.
Sample Package:
No
FDA Application Number:
NDA018830
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
08-02-2011
End Marketing Date:
03-31-2012
Listing Expiration Date:
03-31-2012
Exclude Flag:
D
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 0378-8510-01?

The NDC Packaged Code 0378-8510-01 is assigned to a package of 100 tablet in 1 bottle, plastic of Flecainide Acetate, labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is and is administered via form.

Is NDC 0378-8510 included in the NDC Directory?

No, Flecainide Acetate with product code 0378-8510 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Mylan Pharmaceuticals Inc. on August 02, 2011 and its listing in the NDC Directory is set to expire on March 31, 2012 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0378-8510-01?

The 11-digit format is 00378851001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20378-8510-015-4-200378-8510-01