Dofetilide
Product Images NDC 71410-301

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 71410-301). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Liberty Bioscience 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 (Dofetilide 01)

Chemical structure of Dofetilide, showing its molecular framework including aromatic rings, sulfonamide groups, and ether and amine linkages.*

FDA Label Image

Figure 1 (Dofetilide 02)

A scatter plot with trend lines showing the relationship between mean plasma dofetilide concentration (ng/mL) on the x-axis and mean change from baseline QTc (msec) on the y-axis. Data points compare Day 1 and Day 23 (steady state), with distinct markers for each day.*

FDA Label Image

Figure 2 (Dofetilide 03)

A bar chart comparing the change in QTc interval from baseline at steady state and the probability of remaining in normal sinus rhythm (NSR) at 6 months for placebo and different doses of Dofetilide (125 mcg BID, 250 mcg BID, and 500 mcg BID). Data include 95% confidence intervals represented by error bars and shaded symbols.*

FDA Label Image

Figure 3 (Dofetilide 04)

A Kaplan-Meier survival curve chart showing the probability of remaining in NSR (normal sinus rhythm) over 12 months. It compares four groups: placebo, and Dofetilide at 125 mcg, 250 mcg, and 500 mcg doses given twice daily (BID). The chart includes p-values for each Dofetilide dose from a Log Rank Test indicating statistical significance for the 500 mcg dose.*

FDA Label Image

Figure 4 (Dofetilide 05)

A survival curve chart showing the probability of remaining in NSR (Normal Sinus Rhythm) over 12 months for different doses of Dofetilide (125 mcg, 250 mcg, 500 mcg BID) compared to placebo. The chart includes a p-value log rank test indicating statistical significance for all Dofetilide doses versus placebo.*

FDA Label Image

Figure (Dofetilide 06)

A flowchart illustrating the dosing and monitoring protocol for Dofetilide based on patient telemetry and creatinine clearance levels. It outlines criteria for contraindication, dose adjustments at different creatinine clearance ranges, and instructions for post-dose QTc monitoring and dose modification or discontinuation.*

FDA Label Image

Label Image (Lbl71410300)

The label for Dofetilide 0.125 mg (125 mcg) capsules by Liberty Bioscience LLC features storage instructions, a warning to keep out of reach of children, and a pharmacist note to dispense a medication guide with the product. The package contains 60 capsules with a prescription-only designation.*

FDA Label Image

Label Image (Lbl71410301)

Dofetilide 0.250 mg (250 mcg) capsules packaging label from Liberty BioScience. The label includes storage instructions to keep in a USP tight light-resistant container at 68° to 77°F, child-resistant closure, and protection from moisture and humidity. It states the package contains 60 capsules and notes pharmacist instructions to dispense the accompanying medication guide.*

FDA Label Image

Label Image (Lbl71410302)

Dofetilide 0.500 mg (500 mcg) capsule bottle label from Liberty Bioscience LLC. The label includes storage instructions, safety warnings, the capsule strength, quantity of 60 capsules, and pharmacist dispensing instructions. It notes the drug is Rx only and provides distributor information.*

* 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.