Dofetilide Capsule
Product Images NDC 76282-756

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 76282-756). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Exelan Pharmaceuticals, 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

Flowchart.jpg (Flowchart)

This diagram illustrates dosing adjustment guidelines for oral Dofetilide capsules based on patient telemetry, QTc intervals, and calculated creatinine clearance (Clcr). It includes criteria for when to proceed with Dofetilide, dosage adjustments according to different Clcr ranges, and instructions for post-dose QTc monitoring to guide continuation or discontinuation of therapy.*

FDA Label Image

Fig_1.jpg (Fig 1)

A line graph showing the mean change from baseline QTc interval (in milliseconds) plotted against mean plasma dofetilide concentration (in ng/mL). Data points are displayed for Day 1 and Day 23 (steady state), with separate trend lines illustrating the relationship on each day.*

FDA Label Image

Fig_2.jpg (Fig 2)

A bar chart showing QTc change from baseline (msec) at steady-state and probability of remaining in NSR (%) at 6 months for placebo and three doses of Dofetilide capsules (125 mcg BID, 250 mcg BID, 500 mcg BID). Black circles with error bars represent QTc change with 95% confidence intervals, and gray bars indicate probability of NSR with 95% confidence intervals.*

FDA Label Image

Fig_3.jpg (Fig 3)

A line graph showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for four groups: placebo, and Dofetilide oral capsules at 125 mcg BID, 250 mcg BID, and 500 mcg BID dosages. The plot includes a log rank test p-value table indicating statistical comparisons among the groups.*

FDA Label Image

Fig_4.jpg (Fig 4)

A Kaplan-Meier survival curve showing the probability of remaining in NSR (normal sinus rhythm) over 12 months. Four lines represent groups receiving 125 mcg, 250 mcg, and 500 mcg BID Dofetilide, and a placebo group. A p-value Log Rank Test box compares statistical significance between groups over time.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure of the active ingredient dofetilide, showing the molecular arrangement including sulfonamide and aromatic groups.*

FDA Label Image

0.125mg.jpg (Dofetilide 125mcg)

Label for Dofetilide Capsules 125 mcg (0.125 mg) by Exelan Pharmaceuticals, Inc., showing 60 capsules per package. The label includes dosage information, storage instructions, dispensing directions, and manufacturer details, alongside a barcode and NDC number 76282-755-60.*

FDA Label Image

0.25mg.jpg (Dofetilide 250mcg)

Label for Dofetilide Capsules 250 mcg (0.25 mg) by Exelan Pharmaceuticals, Inc. The label states each capsule contains 250 mcg (0.25 mg) of dofetilide USP and includes storage instructions to protect from moisture and humidity at controlled room temperature. The package contains 60 capsules with a pharmacist dispensing instruction and mentions the medication guide availability online. Manufactured by Granules Pharmaceuticals Inc. for Exelan Pharmaceuticals Inc.*

FDA Label Image

0.5mg.jpg (Dofetilide 500mcg)

Dofetilide Capsules 0.5 mg (500 mcg) oral capsules packaging label showing 60 capsules per container. The label includes dosing instructions, storage conditions, and manufacturer details for Exelan Pharmaceuticals, Inc. The label also mentions dispensing the medication guide to patients and lists Granules Pharmaceuticals, Inc. as the manufacturer.*

* 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.