Dofetilide Capsule
Product Images NDC 0904-7522

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 0904-7522). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Major Pharmaceuticals, 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

500mcg (0.500mg) Carton Label (26de5f8c 8cec 46f6 A468 69451758a278 00)

Dofetilide capsules 500 mcg (0.500 mg) oral unit dose packaging label from Major Pharmaceuticals. The label indicates a package of 40 capsules (4 x 10) with NDC 0904-7524-08. It instructs to dispense with the medication guide and includes storage, handling, and safety information. The product is Rx only.*

FDA Label Image

250mcg (0.250mg) Carton Label (26de5f8c 8cec 46f6 A468 69451758a278 01)

Dofetilide 0.250 mg capsules in a unit dose package by Major Pharmaceuticals. The label shows the strength as 250 mcg (0.250 mg), contains 40 capsules (4 x 10), and is for prescription use only. It includes storage instructions, dispensing guidance, and safety warnings. The product is packaged and distributed by Major Pharmaceuticals in Indianapolis, IN.*

FDA Label Image

125mcg (0.125mg) Carton Label (26de5f8c 8cec 46f6 A468 69451758a278 02)

Dofetilide Capsules 125 mcg (0.125 mg) unit dose packaging label by Major Pharmaceuticals. The label shows the NDC 0904-7522-08, containing 40 capsules in a unit dose format. It includes storage instructions, dispensing guidelines, and notes that the package is not child resistant and intended for institutional use only.*

FDA Label Image

Chemical Structure (Dofetilide 01)

Chemical structure of the active ingredient Dofetilide, showing its molecular composition and bonding arrangement.*

FDA Label Image

Figure 1 (Dofetilide 02)

A line graph depicting the mean change from baseline QTc interval (in milliseconds) versus mean plasma dofetilide concentration (ng/mL) at Day 1 and Day 23 (steady state). The graph uses squares for Day 1 data points and diamonds for Day 23, with lines showing trends for each day.*

FDA Label Image

Figure 2 (Dofetilide 03)

Bar and dot plot comparing the change in QTc interval from baseline and the probability of remaining in normal sinus rhythm (NSR) at 6 months for placebo and three doses of Dofetilide capsules: 125 mcg BID, 250 mcg BID, and 500 mcg BID. The left Y-axis shows QTc change in milliseconds with 95% confidence intervals, and the right Y-axis shows the probability of remaining in NSR percentage with 95% confidence intervals.*

FDA Label Image

Figure 3 (Dofetilide 04)

A Kaplan-Meier survival curve chart showing the probability of remaining in normal sinus rhythm (NSR) over time (months) for patients treated with three dosages of dofetilide (125 mcg BID, 250 mcg BID, 500 mcg BID) compared to placebo. The chart includes p-values from Log Rank Tests for each dosage group versus placebo.*

FDA Label Image

Figure 4 (Dofetilide 05)

A Kaplan-Meier survival curve graph showing the probability of remaining in NSR (normal sinus rhythm) over 12 months. The graph compares four groups: placebo and three doses of dofetilide (125 mcg BID, 250 mcg BID, and 500 mcg BID). Probability decreases over time, with higher doses of dofetilide maintaining higher probabilities of NSR. A p-value log rank test box indicates statistical significance for all dofetilide doses compared to placebo.*

FDA Label Image

Figure (Dofetilide 06)

A flowchart outlining the dosing adjustment process for Dofetilide capsules based on patient telemetry, baseline QTc or QT intervals, and calculated creatinine clearance (Clcr). It includes specific dosing recommendations and criteria for contraindication and dose adjustment after monitoring QTc or QT changes post dose.*

* 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.