Dofetilide Capsule
Product Images NDC 70518-4617

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 70518-4617). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack Inc., 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

Mm1 (Dofetilide 250mcg(0.25mg) 70518 4617 00)

Dofetilide Capsule 0.25 mg oral capsules, packaged 50 per box. The label includes handling instructions to protect the product from moisture and humidity. It is repackaged by RemedyRepack Inc., Indiana, PA. The label shows the NDC number 70518-4617-00 and specifies storage temperature between 20-25°C with some excursions permitted. Manufacturer details list Novadoz Pharmaceuticals LLC, Piscataway, NJ.*

FDA Label Image

Mm2 (Dofetilide 250mcg(0.25mg) 70518 4617 01)

Dofetilide 0.25 mg capsule label showing a single tablet quantity. The label includes the NDC number 70518-4617-01 and states the capsule color as pink. The labeler is RemedyRepack Inc. with repackaging information from Indiana, PA. Storage instructions and a manufacturer NDC for Novadoz Pharmaceuticals LLC are also visible.*

FDA Label Image

Gualt-eq (Dofetilide Capsules Gault Eq)

A flowchart diagram detailing the dosing and monitoring guidelines for oral dofetilide. It begins with placing the patient on telemetry, checking baseline QTc or QT intervals, and calculating creatinine clearance (Clcr) with formulas for males and females. Based on Clcr values, dosing recommendations for dofetilide are given in micrograms BID. Post-dose adjustments include QTc or QT checks 2-3 hours after the dose and instructions for dose continuation, reduction, or discontinuation based on increases in QTc or QT intervals.*

FDA Label Image

Fig01 (Dofetilide Figure 01)

A scatter plot graph illustrating the relationship between mean plasma dofetilide concentration (ng/mL) on the x-axis and mean change from baseline QTc interval (msec) on the y-axis. Data points are shown for Day 1 and Day 23 (steady state), with linear trend lines for each set.*

FDA Label Image

Fig02 (Dofetilide Figure 02)

A bar chart comparing the QTc change from baseline at steady state in milliseconds for placebo and three dosages of dofetilide (125 mcg BID, 250 mcg BID, 500 mcg BID). The chart includes 95% confidence intervals and a secondary y-axis showing the probability of remaining in NSR at 6 months as percentages with error bars.*

FDA Label Image

Fig-03 (Dofetilide Figure 03)

A survival curve chart showing the probability of remaining in NSR over time (months) for four groups: 500 mcg BID Dofetilide, 250 mcg BID Dofetilide, 125 mcg BID Dofetilide, and placebo. The chart includes p-values from a log-rank test for each dose compared to placebo.*

FDA Label Image

Fig-04 (Dofetilide Figure 04)

A Kaplan-Meier survival curve showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for four groups: placebo, 125 mcg, 250 mcg, and 500 mcg doses of dofetilide given twice daily (BID). The plot indicates higher doses of dofetilide are associated with a greater probability of maintaining NSR over time, with statistical significance noted by p-values for each dose group versus placebo.*

FDA Label Image

Struct (Structure)

Chemical structure of the active ingredient Dofetilide, showing its molecular arrangement including sulfonamide and aromatic ring components.*

* 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.