Dofetilide 0.5mg Capsule
Product Images NDC 70010-026

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide 0.5mg (NDC 70010-026). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Granules 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

Dofetilide-125label-jpg (Dofetilide 125label Jpg)

Label for Dofetilide Capsules 125 mcg (0.125 mg) manufactured by Granules Pharmaceuticals Inc. The label indicates a package of 60 oral capsules with instructions for pharmacists to dispense the enclosed Medication Guide. It includes storage instructions, dosage reference, and a barcode alongside the NDC 70010-024-06.*

FDA Label Image

Dofetilide-250label-jpg (Dofetilide 250label Jpg)

Label for Dofetilide Capsules 0.25 mg oral medication by Granules Pharmaceuticals Inc. The label states each capsule contains 250 mcg (0.25 mg) of dofetilide USP. It includes instructions for dispensing and storage, the package contains 60 capsules, and the label shows the NDC number 70010-025-06.*

FDA Label Image

Dofetilide-500label-jpg (Dofetilide 500label Jpg)

Label for Dofetilide Capsules 0.5 mg by Granules Pharmaceuticals Inc. The label states 60 capsules per container, with each capsule containing 500 mcg (0.5 mg) of dofetilide USP. Instructions note prescription use only, pharmacist guidance to dispense the Medication Guide, and storage conditions between 20° to 25°C (68° to 77°F). The label includes handling and moisture protection information, a barcode, and manufacturer details.*

FDA Label Image

Dofetilide-figure1-jpg (Dofetilide Figure1 Jpg)

A scatter plot with trend lines illustrating the relationship between mean plasma dofetilide concentration (ng/mL) on the x-axis and mean change from baseline QTc (msec) on the y-axis. Data points represent values from Day 1 and Day 23 (steady state), showing a trend of increasing QTc with increasing dofetilide concentration.*

FDA Label Image

Dofetilide-figure2-jpg (Dofetilide Figure2 Jpg)

A bar chart showing the change in QTc from baseline at steady state in milliseconds on the left y-axis and the probability of remaining in NSR at 6 months on the right y-axis. The x-axis compares placebo and three doses of dofetilide (125 mcg BID, 250 mcg BID, 500 mcg BID). Bars represent QTc changes with error bars, and black circles indicate the probability of NSR with confidence intervals.*

FDA Label Image

Dofetilide-figure3-jpg (Dofetilide Figure3 Jpg)

A Kaplan-Meier survival curve chart showing the probability of remaining in normal sinus rhythm (NSR) over 12 months. The graph compares four groups: placebo and three doses of dofetilide (125 mcg BID, 250 mcg BID, and 500 mcg BID). The chart includes p-values from a Log Rank Test for each dose against placebo.*

FDA Label Image

Dofetilide-figure4-jpg (Dofetilide Figure4 Jpg)

A line graph showing the probability of remaining in NSR (normal sinus rhythm) over a 12-month period for patients on different doses of Dofetilide (125 mcg, 250 mcg, 500 mcg twice daily) compared to placebo. The graph includes a p-value log rank test indicating statistical significance for each Dofetilide dose versus placebo.*

FDA Label Image

Dofetilide-flow-chart-jpg (Dofetilide Flow Chart Jpg)

Flowchart diagram showing dosing adjustment and monitoring guidelines for Dofetilide 0.25mg oral capsules. It details telemetry placement, baseline QTc/QT interval checks, calculated creatinine clearance formulas for males and females, contraindications if clearance is below 20 mL/min, and dosing recommendations based on creatinine clearance ranges. It also includes instructions for post-dose QT interval monitoring and dose adjustments or discontinuation based on QTc/QT increase percentages or absolute values.*

FDA Label Image

Dofetilide-structure-jpg (Dofetilide Structure Jpg)

Chemical structure of dofetilide, showing its molecular features including aromatic rings, sulfur-oxygen groups, and nitrogen atoms, consistent with its known chemical composition.*

* 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.