Dofetilide Capsule
Product Images NDC 16729-492

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 16729-492). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare, 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

Chemical Structure (Dofetilide 01)

Chemical structure diagram of dofetilide, illustrating its molecular formula with phenyl rings and sulfonamide functional groups as labeled in the image.*

FDA Label Image

Figure 1 (Dofetilide 02)

A scatter plot displaying mean change from baseline QTc (milliseconds) versus mean plasma dofetilide concentration (ng/mL). The graph compares data from Day 1 (open squares with a solid trend line) and Day 23 at steady state (filled diamonds with a dashed trend line), illustrating the relationship between plasma concentration and QTc change over time.*

FDA Label Image

Figure 2 (Dofetilide 03)

A bar chart comparing QTc change from baseline (msec) at steady state and probability of remaining in NSR (%) at 6 months for placebo and three doses of Dofetilide (125 mcg BID, 250 mcg BID, 500 mcg BID). Each bar shows mean values with error bars representing 95% confidence intervals for both QTc change and NSR probability.*

FDA Label Image

Figure 3 (Dofetilide 04)

A Kaplan-Meier survival curve chart displaying the probability of remaining in normal sinus rhythm (NSR) over 12 months. Four lines represent groups: placebo and Dofetilide oral doses at 0.125 mg, 0.25 mg, and 0.5 mg twice daily. The chart includes p-values from a log-rank test comparing each Dofetilide dose to placebo.*

FDA Label Image

Figure 4 (Dofetilide 05)

A line graph showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for different doses of Dofetilide capsules (125 mcg BID, 250 mcg BID, 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 from a Log Rank Test for each Dofetilide dose versus placebo.*

FDA Label Image

Flow Chart (Dofetilide 06)

An instructional flowchart outlining the dosing and monitoring guidelines for oral Dofetilide capsules. It includes steps for baseline QTc assessment, calculation of creatinine clearance for dosing decisions, dose adjustments based on creatinine clearance ranges, and post-dose QTc monitoring to guide continuation or discontinuation of therapy.*

FDA Label Image

Principal Display Panel (0.125 mg Capsule Bottle Label)

Label for Dofetilide Capsules 125 mcg (0.125 mg) by Accord Healthcare, Inc. The label includes storage instructions, dosage strength, and directions to dispense the enclosed Medication Guide. The package contains 60 capsules and features barcodes and manufacturer information.*

FDA Label Image

Principal Display Panel (0.25 mg Capsule Bottle Label)

Label for Dofetilide Capsules 250 mcg (0.25 mg) oral capsules by Accord Healthcare, Inc. The label includes storage instructions to store at 15°C to 30°C and protect from moisture and humidity. It notes the package contains 60 capsules and is for prescription use only, with manufacturing details from Accord Healthcare, Inc. and Intas Pharmaceuticals Limited. The label features two barcodes and a purple box reserved for lot and expiration data matrix.*

FDA Label Image

Principal Display Panel (0.5 mg Capsule Bottle Label)

Label for Dofetilide Capsules 500 mcg (0.5 mg) by Accord Healthcare, Inc., showing the product name, strength, oral capsule dosage form, and package quantity of 60 capsules. The label includes storage instructions, manufacturer details, and barcodes.*

* 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.