Dofetilide Capsule
Product Images NDC 72603-130

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 72603-130). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rxllc, 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

Dofetilide-figure1 (Dofetilide Figure1)

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. Two data sets are presented: Day 1 (open squares) and Day 23 steady state (filled diamonds), with corresponding trend lines indicating changes over time.*

FDA Label Image

Dofetilide-figure2 (Dofetilide Figure2)

A bar and scatter plot chart comparing QTc change from baseline at steady state (in milliseconds) and probability of remaining in NSR at 6 months (percentage) for placebo and three doses of Dofetilide (125 mcg, 250 mcg, 500 mcg BID). QTc change is indicated by circles with 95% confidence intervals, and probability of NSR is shown by gray or striped bars with 95% confidence intervals. The chart shows increasing QTc change and probability of NSR with higher doses of Dofetilide compared to placebo.*

FDA Label Image

Dofetilide-figure3 (Dofetilide Figure3)

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 (BID), compared to a placebo. The chart includes a p-value log rank test summary for each dose versus placebo.*

FDA Label Image

Dofetilide-figure4 (Dofetilide Figure4)

A Kaplan-Meier survival curve showing the probability of remaining in NSR (normal sinus rhythm) over 12 months. The graph compares 500 mcg, 250 mcg, and 125 mcg doses of dofetilide taken twice daily (BID) to placebo, with corresponding p-values from a log-rank test indicating statistical significance for each dose versus placebo.*

FDA Label Image

Dofetilide-figure5 (Dofetilide Figure5)

A flowchart showing dosing and monitoring instructions for dofetilide. It includes steps for placing the patient on telemetry, checking baseline QTc or QT intervals, calculating creatinine clearance with formulas for males and females, and adjusting dofetilide dose based on creatinine clearance ranges. Post-dose QTc or QT is monitored, with recommendations to adjust or discontinue dofetilide based on QT interval changes.*

FDA Label Image

Dofetilide-structure (Dofetilide Structure)

Chemical structure of dofetilide, showing the molecule's arrangement with sulfonamide, aromatic rings, and ether linkages.*

FDA Label Image

Spl-dofetilide-label-125mcg (Spl Dofetilide Label 125mcg)

Label for Dofetilide Capsules 125 mcg (0.125 mg) oral capsules by NorthStar Rx LLC. The label states each capsule contains 125 mcg (0.125 mg) dofetilide and that there are 60 capsules per container. It includes storage instructions, manufacturer information, and a barcode.*

FDA Label Image

Spl-dofetilide-label-250mcg (Spl Dofetilide Label 250mcg)

Dofetilide Capsules 0.25 mg (250 mcg) oral capsules label by NorthStar Rx LLC. The bottle contains 60 capsules. The label includes storage instructions, manufacturer details, a barcode, and a note to dispense with a medication guide. Manufactured by Sun Pharmaceutical Industries Limited in India.*

FDA Label Image

Spl-dofetilide-label-500mcg (Spl Dofetilide Label 500mcg)

Dofetilide Capsules 500 mcg (0.5 mg) oral capsule label from NorthStar Rx LLC. The label states a package count of 60 capsules, with storage instructions to keep between 20° to 25°C and protect from moisture. It includes manufacturing information from Sun Pharmaceutical Industries Limited in India and directs pharmacists to dispense with a Medication Guide.*

* 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.