Dofetilide Capsule
Product Images NDC 47335-061

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 47335-061). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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

Dofetilide-figure1 (Dofetilide Figure1)

A scatter plot graph depicting the relationship between mean plasma dofetilide concentration (ng/mL) on the x-axis and mean change from baseline QTc (milliseconds) on the y-axis. Data points are shown for Day 1 and Day 23 (Steady State), each with fitted trend lines, illustrating how QTc changes with plasma levels of dofetilide.*

FDA Label Image

Dofetilide-figure2 (Dofetilide Figure2)

A bar chart comparing QTc change from baseline at steady state (msec) and probability of remaining in normal sinus rhythm (NSR) at 6 months (%) across groups receiving placebo or different doses of dofetilide (125 mcg BID, 250 mcg BID, and 500 mcg BID). QTc change is shown with black circular markers and 95% confidence intervals, while the probability of NSR is represented by bars with 95% confidence intervals, highlighting dose-dependent effects of dofetilide.*

FDA Label Image

Dofetilide-figure3 (Dofetilide Figure3)

A Kaplan-Meier survival curve chart depicting the probability of remaining in NSR (normal sinus rhythm) over time (months) for different doses of Dofetilide (125 mcg, 250 mcg, 500 mcg BID) and placebo. The x-axis represents time in months, and the y-axis shows the probability of remaining in NSR. The chart includes a p-value log-rank test for each dose compared to placebo.*

FDA Label Image

Dofetilide-figure4 (Dofetilide Figure4)

A Kaplan-Meier survival curve chart showing the probability of remaining in NSR (normal sinus rhythm) over 12 months. The curves compare placebo and three doses of Dofetilide (125 mcg, 250 mcg, and 500 mcg BID) with higher doses showing higher probabilities of remaining in NSR. A p-value Log Rank Test box indicates statistically significant differences for all Dofetilide doses versus placebo.*

FDA Label Image

Dofetilide-figure5 (Dofetilide Figure5)

Flowchart illustrating dosing guidelines for DOFETILIDE capsules based on patient telemetry, baseline QTc/QT intervals, and calculated creatinine clearance. It includes contraindications for low clearance, dosing adjustments for different clearance ranges, post-dose QTc/QT monitoring, and dose modification instructions depending on QTc/QT changes after dosing.*

FDA Label Image

Dofetilide-label1 (Dofetilide Label1)

Label for Dofetilide Capsules 125 mcg (0.125 mg) strength. The label specifies the dosage form as capsules with a quantity of 60 capsules per container. It includes storage instructions, a barcode, and manufacturing details by Sun Pharmaceutical Industries Limited. The labeler is Sun Pharmaceutical Industries, Inc., Cranbury, NJ.*

FDA Label Image

Dofetilide-label2 (Dofetilide Label2)

Label for Dofetilide Capsules 0.25 mg strength, containing 60 capsules. The label states storage instructions, dosage guidance, and manufacturer information for Sun Pharmaceutical Industries, Inc. The NDC is 47335-062-86, and it includes a barcode and a note to dispense with a Medication Guide.*

FDA Label Image

Dofetilide-label3 (Dofetilide Label3)

Dofetilide Capsules 500 mcg (0.5 mg) oral capsules label. The label includes dosage strength, instructions for pharmacists to dispense with a medication guide, and states Rx only with a package containing 60 capsules. Manufactured by Sun Pharmaceutical Industries, Inc. The label also provides storage conditions and protection instructions, along with barcode and manufacturer details.*

FDA Label Image

Dofetilide-showbox1 (Dofetilide Showbox1)

Dofetilide Capsules 0.125 mg oral dosage form shown in a package label. The label states 40 capsules in a unit-dose format (4 x 10). It is a human prescription drug marketed by Sun Pharmaceutical Industries, Inc. The label includes storage instructions and distributor/manufacturer information.*

FDA Label Image

Dofetilide-showbox2 (Dofetilide Showbox2)

Dofetilide Capsules 0.25 mg (250 mcg) oral unit-dose packaging containing 40 capsules (4 x 10). Label instructs dispensing with Medication Guide and indicates institutional use only. Distributed and manufactured by Sun Pharmaceutical Industries, Inc. and Sun Pharmaceutical Industries Limited, respectively.*

FDA Label Image

Dofetilide-showbox3 (Dofetilide Showbox3)

Dofetilide Capsules 0.5 mg oral capsules packaging label showing 40 capsules in 4 unit-dose strips of 10. Label includes directions for pharmacists to dispense with Medication Guide, states for institutional use only, and provides storage instructions. Distributed by Sun Pharmaceutical Industries, Inc. and manufactured by Sun Pharmaceutical Industries Limited in India.*

FDA Label Image

Dofetilide-structure (Dofetilide Structure)

Chemical structure diagram of dofetilide, showing the molecular connections including aromatic rings, sulfonamide groups, and ether linkage typical of this active ingredient.*

* 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.