Dofetilide Capsule
NDC Package 75907-055-60

11-digit billing NDC: 75907005560 · Billing unit: EA · 60 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Dofetilide capsules are contraindicated in patients with congenital or acquired long QT syndromes. This formulation utilizes a capsule delivery system. Marketed by Dr. Reddy's Labratories Inc., this product is identified by NDC 75907-055 and is authorized under FDA application ANDA207058.

Identification & Billing

NDC Package Code
75907-055-60
Package Description
60 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
75907-055
11-Digit Billing Format
75907005560
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
Non-Proprietary Name
Dofetilide
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 .25 mg/1
Pharmacologic Class
Antiarrhythmic - [EPC] (Established Pharmacologic Class)
Usage Information
Dofetilide capsules are contraindicated in patients with congenital or acquired long QT syndromes. Dofetilide capsules should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients with ventricular conduction abnormalities). Dofetilide capsules are also contraindicated in patients with severe renal impairment (calculated creatinine clearance <20 mL/min).The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with dofetilide capsules is contraindicated (see WARNINGS and PRECAUTIONS, Drug-Drug Interactions), as each of these drugs cause a substantial increase in dofetilide plasma concentrations. In addition, other known inhibitors of the renal cation transport system such as prochlorperazine, dolutegravir and megestrol should not be used in patients on dofetilide capsules.The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with dofetilide capsules is contraindicated (see PRECAUTIONS, Drug-Drug Interactions) because this has been shown to significantly increase dofetilide plasma concentrations and QT interval prolongation.Dofetilide capsules are also contraindicated in patients with a known hypersensitivity to the drug.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Labratories Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207058
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2024
End Marketing Date
01-31-2027
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 75907-055-60 identifies a specific commercial package of 60 capsule in 1 bottle, plastic of Dofetilide, a human prescription drug labeled by Dr. Reddy's Labratories 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 Dr. Reddy's Labratories Inc. on May 28, 2024.

How is this Dr. Reddy's Labratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75907005560. 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)
75907-055-60
11-Digit CMS (5-4-2)
75907-0055-60

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