Dofetilide Capsule
Product Images NDC 42794-045

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 42794-045). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sigmapharm Laboratories, Llc, 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

Chemical Structure (Dc 1)

Chemical structure of the active ingredient dofetilide, showing its aromatic rings and functional groups including methyl sulfonamide and ether linkages.*

FDA Label Image

Figure 1 (Dc 2)

A line graph comparing mean change from baseline QTc (msec) versus mean plasma dofetilide concentration (ng/mL) on Day 1 and Day 23 (steady state). Day 1 data are shown with square markers and a solid line, while Day 23 data are indicated with diamond markers and a dashed line, illustrating different QTc change responses at varying plasma concentrations.*

FDA Label Image

Figure 2 (Dc 3)

A bar graph showing QTc change from baseline at steady state (in msec) and the probability of remaining in normal sinus rhythm (NSR) at 6 months (%) for Placebo and three doses of Dofetilide capsules (125 mcg BID, 250 mcg BID, 500 mcg BID). Each bar has error bars representing 95% confidence intervals for QTc change and probability of NSR.*

FDA Label Image

Figure 3 (Dc 4)

A Kaplan-Meier survival curve chart showing the probability of remaining in NSR (normal sinus rhythm) over time in months for patients treated with Dofetilide at doses 125 mcg BID, 250 mcg BID, 500 mcg BID, and placebo. The chart includes a log-rank test p-value comparison for each dose versus placebo, indicating the statistical significance of the differences observed over a 12-month duration.*

FDA Label Image

Figure 4 (Dc 5)

A line graph showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for different doses of Dofetilide capsules (125 mcg, 250 mcg, 500 mcg BID) compared to placebo. The x-axis represents time in months, and the y-axis represents the probability of remaining in NSR. The graph includes p-values for the Log Rank Test for each Dofetilide dose versus placebo.*

FDA Label Image

Flow Chart (Dc 6)

A flowchart illustrating dosing and monitoring guidelines for Dofetilide use. It starts with placing the patient on telemetry, checking baseline QTc or QT intervals, calculating creatinine clearance for dose adjustment, and contraindication if clearance is below 20 mL/min. It specifies dosing based on creatinine clearance ranges, followed by post-dose QTc or QT monitoring and dose adjustment instructions depending on changes in QTc or QT intervals after the first dose and beyond.*

FDA Label Image

Principal Display Panel (125 mcg (0.125 mg) Capsules Bottle Label)

Dofetilide Capsules 125 mcg (0.125 mg) oral capsules in a 60-count package from Sigmapharm Laboratories, LLC. The label includes storage instructions, a pharmacist dispensing note, and a barcode.*

FDA Label Image

Principal Display Panel (250 mcg (0.25 mg) Capsules Bottle Label)

Label for Dofetilide Capsules 250 mcg (0.25 mg) by Sigmapharm Laboratories, LLC. The label specifies the product as a prescription oral capsule with 60 capsules per bottle. Storage instructions and dispensing directions for pharmacists are included, along with the NDC number 42794-045-10 and a barcode.*

FDA Label Image

Principal Display Panel (500 mcg (0.5 mg) Capsules Bottle Label)

Dofetilide Capsules 500 mcg (0.5 mg) oral capsules packaging label by Sigmapharm Laboratories, LLC. The label states the package contains 60 capsules and includes storage directions and dispensing instructions for pharmacists. The NDC code is 42794-046-10.*

* 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.