Dofetilide
NDC Package 71410-302-06

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 inactivated by the FDA.

Dofetilide is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation/flutter). Marketed by Liberty Bioscience Llc, this product is identified by NDC 71410-302 and is authorized under FDA application ANDA207058.

Identification & Billing

NDC Package Code
71410-302-06
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
71410-302
11-Digit Billing Format
71410030206
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dofetilide
Dosage Form
-
Usage Information
This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation/flutter). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Dofetilide is known as an anti-arrhythmic drug. It works by blocking the activity of 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.

Regulatory & Marketing

Labeler Name
Liberty Bioscience Llc
FDA Application #
ANDA207058
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-07-2016
Listing Expiration
12-31-2020
Exclude Flag
I
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 71410-302-06 identifies a specific commercial package of 60 capsule in 1 bottle of Dofetilide, labeled by Liberty Bioscience Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Liberty Bioscience Llc on June 07, 2016. The current certification is valid through December 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 atrial fibrillation/flutter). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. Dofetilide is known as an anti-arrhythmic drug. It works by blocking the activity of 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.

How is this Liberty Bioscience Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71410030206. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (5-3-2)
71410-302-06
11-Digit CMS (5-4-2)
71410-0302-06

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