Dofetilide 0.125mg Capsule
NDC Package 70010-024-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dofetilide 0.125mg capsules is a medication used to treat certain types of serious (possibly fatal) irregular heartbeat (such as atrial fibrillation/flutter). This formulation utilizes a capsule delivery system. Marketed by Granules Pharmaceuticals Inc., this product is identified by NDC 70010-024 and is authorized under FDA application ANDA212750.

Identification & Billing

NDC Package Code
70010-024-06
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
70010-024
11-Digit Billing Format
70010002406
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dofetilide 0.125mg
Non-Proprietary Name
Dofetilide 0.125mg
Substance Name
Dofetilide
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOFETILIDE .125 mg/1
Pharmacologic Class
Antiarrhythmic - [EPC] (Established Pharmacologic Class)
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
Granules Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212750
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 70010-024-06 identifies a specific commercial package of 60 capsule in 1 bottle of Dofetilide 0.125mg, a human prescription drug labeled by Granules Pharmaceuticals Inc.. This capsule is formulated for oral 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 Granules Pharmaceuticals Inc. on November 14, 2024. The current certification is valid through December 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 Granules Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70010002406. 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)
70010-024-06
11-Digit CMS (5-4-2)
70010-0024-06

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