Dofetilide Powder
NDC Package 60715-2811-1

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.

Dofetilide powders is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation/flutter). This formulation utilizes a powder delivery system. Marketed by Pfizer Ireland Pharmaceuticals Unlimited Company, this product is identified by NDC 60715-2811.

Identification & Billing

NDC Package Code
60715-2811-1
Package Description
1 BAG in 1 DRUM / 2 kg in 1 BAG (60715-2811-5)
Product Code
60715-2811
11-Digit Billing Format
60715281101

Clinical Specifications

Proprietary Name
Dofetilide
Non-Proprietary Name
Dofetilide
Substance Name
Dofetilide
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)
DOFETILIDE 1 kg/kg
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
Pfizer Ireland Pharmaceuticals Unlimited Company
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-25-2011
Listing Expiration
12-31-2027
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 60715-2811-1 identifies a specific commercial package of 1 bag in 1 drum / 2 kg in 1 bag (60715-2811-5) of Dofetilide (UNFINISHED drug), a bulk ingredient labeled by Pfizer Ireland Pharmaceuticals Unlimited Company. This powder is formulated for use and contains dofetilide 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 Pfizer Ireland Pharmaceuticals Unlimited Company on February 25, 2011. The current certification is valid through December 31, 2027.

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 Pfizer Ireland Pharmaceuticals Unlimited Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60715281101. 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)
60715-2811-1
11-Digit CMS (5-4-2)
60715-2811-01

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