Dofetilide
NDC Package 0904-6683-08

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 Major Pharmaceuticals, this product is identified by NDC 0904-6683 and is authorized under FDA application ANDA207058.

Identification & Billing

NDC Package Code
0904-6683-08
Package Description
40 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK
Product Code
0904-6683
11-Digit Billing Format
00904668308

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
Major Pharmaceuticals
FDA Application #
ANDA207058
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-07-2016
End Marketing Date
01-31-2026
Listing Expiration
01-31-2026
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 0904-6683-08 identifies a specific commercial package of 40 blister pack in 1 carton / 1 capsule in 1 blister pack of Dofetilide, labeled by Major Pharmaceuticals. 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 Major Pharmaceuticals on June 07, 2016. The current certification is valid through January 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 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 Major Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00904668308. 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 (4-4-2)
0904-6683-08
11-Digit CMS (5-4-2)
00904-6683-08

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