Dofetilide
Product Images NDC 84280-5250

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 84280-5250). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by The Janz Corporation, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Gualt-eq (Dofetilide Capsules Gault Eq)

An instructional flowchart illustrating the dosing adjustment protocol for Dofetilide. It outlines steps starting with placing the patient on telemetry, checking baseline QTc or QT intervals, calculating creatinine clearance (Clcr) with formulas for males and females, and determining dosing based on Clcr levels. It includes instructions for dose adjustments after the first dose based on QTc or QT changes and when to discontinue dofetilide if QTc or QT increases exceed specific thresholds.*

FDA Label Image

Fig01 (Dofetilide Figure 01)

A line graph depicting mean change from baseline QTc interval (msec) versus mean plasma dofetilide concentration (ng/mL). Two data sets are shown: Day 1 with increasing values and Day 23 (Steady State) with generally lower values, each represented by distinct markers and trend lines.*

FDA Label Image

Fig02 (Dofetilide Figure 02)

A bar and scatter plot chart showing the QTc change from baseline and probability of remaining in NSR at steady state for placebo and various doses of Dofetilide (125mcg BID, 250mcg BID, 500mcg BID). The x-axis lists the treatment groups, the left y-axis indicates QTc change in milliseconds, and the right y-axis shows the probability of remaining in NSR at 6 months in percentage.*

FDA Label Image

Fig-03 (Dofetilide Figure 03)

A Kaplan-Meier survival plot showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for Dofetilide at doses of 500 mcg BID, 250 mcg BID, 125 mcg BID, and placebo. The plot compares the efficacy of these dosing regimens over time.*

FDA Label Image

Fig-04 (Dofetilide Figure 04)

A Kaplan-Meier survival plot showing the probability of remaining in NSR (normal sinus rhythm) over a 12-month period. The graph compares four groups: 500 mcg BID Dofetilide, 250 mcg BID Dofetilide, 125 mcg BID Dofetilide, and placebo, with p-values for the Log Rank Test listed for each Dofetilide dosage versus placebo.*

FDA Label Image

Image Description (Image 125 Mcg Cap)

Label for Dofetilide Capsules 125 mcg (0.125 mg), containing 60 capsules. The label includes storage instructions (15° to 30°C), pharmacist dispensing guidance, manufacturer details (MSN Laboratories Private Limited for Janz Corporation), and distributor information (Novadoz Pharmaceuticals LLC). It also features a barcode and contact details for Novadoz Pharmaceuticals.*

FDA Label Image

Image Description (Image 250 Mcg Cap)

Dofetilide Capsules 250 mcg (0.25 mg) label for a 60-capsule package. The label includes dosage strength, storage instructions, pharmacist dispensing reminder, and manufacturing/distribution information by Janz Corporation and Novadoz Pharmaceuticals LLC. It features barcodes and a website for the medication guide.*

FDA Label Image

Image Description (Image 500 Mcg Cap)

Label for Dofetilide Capsules 500 mcg (0.5 mg), containing 60 capsules. The label states the product is Rx Only and instructs pharmacists to dispense the accompanying Medication Guide. It lists the manufacturer as MSN Laboratories Private Limited in India for Janz Corporation and distributor as Novadoz Pharmaceuticals, Piscataway, NJ. Storage instructions include keeping at 15° to 30°C and protecting from moisture and humidity. Contact information for Novadoz is provided along with a barcode and NDC 84280-5500-60.*

FDA Label Image

Struct (Structure)

Chemical structure of Dofetilide, showing the molecular arrangement including aromatic rings, sulfonamide groups, and methyl substituents, corresponding to the active ingredient in the product labeled by The Janz Corporation.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.