Dofetilide Capsule
Product Images NDC 70518-4738

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 70518-4738). 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 125mcg ( 0.125mg) 70518 4738 00)

Dofetilide capsule 0.125 mg in a box of 100 capsules. The label shows the NDC 70518-4738-00 and indicates the capsules are orange of size MD 1. The label is repackaged by RemedyRepack Inc., Indiana, PA. It includes storage instructions and the original manufacturer, Novadoz Pharma LLC, Piscataway, NJ.*

FDA Label Image

Mm2 (Dofetilide 125mcg ( 0.125mg) 70518 4738 01)

Dofetilide Capsule 0.125 mg oral capsules, orange in color, packaged 50 per box. The label includes the NDC number 70518-4738-01 and indicates the product is repackaged by RemedyRepack Inc., Indiana, PA. Storage instructions specify protection from moisture and humidity, with temperature guidelines of 20-25°C and excursions allowed between 15-30°C. The manufacturer is Novadoz Pharma LLC, Piscataway, NJ.*

FDA Label Image

Remedy_label (Remedy Label)

Dofetilide Capsule 0.125 mg, oral dosage form, single capsule quantity. Label shows NDC 70518-4738-02, orange capsule color code MD:1, repackaged by RemedyRepack Inc. in Indiana, PA. Includes storage instructions and manufacturer info for Novadoz Pharma LLC, Piscataway, NJ.*

FDA Label Image

Gualt-eq (Dofetilide Capsules Gault Eq)

A flowchart illustrating dosing guidelines and monitoring steps for Dofetilide based on patient telemetry and creatinine clearance levels. It includes decision points for QTc or QT intervals, creatinine clearance calculations for males and females, dose adjustments for varying renal function, and criteria for continuing, adjusting, or discontinuing therapy according to QT interval changes.*

FDA Label Image

Fig01 (Dofetilide Figure 01)

A scatter plot showing 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 plotted for Day 1 and Day 23 (steady state), with trend lines for each set of points illustrating the changes over concentrations.*

FDA Label Image

Fig02 (Dofetilide Figure 02)

A bar graph comparing changes from baseline in QTc interval and the probability of remaining in NSR at 6 months (%) for placebo and three doses of Dofetilide (125 mcg BID, 250 mcg BID, 500 mcg BID). Bars show mean QTc change with 95% confidence intervals, with higher doses of Dofetilide associated with increased QTc changes and variable probabilities of NSR maintenance.*

FDA Label Image

Fig-03 (Dofetilide Figure 03)

A Kaplan-Meier survival curve chart showing the probability of remaining in NSR (normal sinus rhythm) over time in months. The graph compares four groups: placebo, 125 mcg BID Dofetilide, 250 mcg BID Dofetilide, and 500 mcg BID Dofetilide, with a legend of p-values from Log Rank Test for each dose compared to placebo.*

FDA Label Image

Fig-04 (Dofetilide Figure 04)

A Kaplan-Meier survival curve chart showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for Dofetilide at doses of 125 mcg, 250 mcg, and 500 mcg twice daily compared to placebo. The curves illustrate higher probabilities of remaining in NSR with increasing doses of Dofetilide versus placebo, with significance indicated by p-values from a Log Rank Test.*

FDA Label Image

Struct (Structure)

Chemical structure of dofetilide showing its molecular arrangement with sulfonamide, aromatic rings, ether, and amine groups in the chemical formula.*

* 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.