Dofetilide
NDC Package 42291-413-60

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.

Dofetilide is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation/flutter). Marketed by Avkare, this product is identified by NDC 42291-413 and is authorized under FDA application ANDA207746.

Identification & Billing

NDC Package Code
42291-413-60
Package Description
60 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
42291-413
11-Digit Billing Format
42291041360
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

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
Avkare
FDA Application #
ANDA207746
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-06-2018
End Marketing Date
09-30-2022
Listing Expiration
09-30-2022
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 42291-413-60 identifies a specific commercial package of 60 capsule in 1 bottle, plastic of Dofetilide, labeled by Avkare. 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 Avkare on August 06, 2018. The current certification is valid through September 30, 2022.

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 Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291041360. 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)
42291-413-60
11-Digit CMS (5-4-2)
42291-0413-60

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