Dofetilide 0.125mg Capsule
Product Images NDC 70010-024

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide 0.125mg (NDC 70010-024). 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-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.*

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-125mcg (Dofetilide 125mcg)

Label for Dofetilide capsules 0.125 mg by Granules Pharmaceuticals Inc., Chantilly, VA. The label indicates each capsule contains 125 mcg (0.125 mg) of dofetilide USP. The package contains 60 capsules, prescription only. Storage instructions specify keeping the product at 20° to 25°C (68° to 77°F) and protecting from moisture and humidity. The label includes a medication guide URL and pharmacist dispensing instructions.*

FDA Label Image

Dofetilide-250mcg (Dofetilide 250mcg)

Label for Dofetilide Capsules 250 mcg (0.25 mg) oral capsules by Granules Pharmaceuticals Inc. The label indicates 60 capsules per container with dosage strength prominently displayed. It includes storage instructions to protect from moisture and maintain temperature between 20° to 25°C (68° to 77°F). The label also directs pharmacists to dispense the medication guide separately and provides a URL for additional information.*

FDA Label Image

Dofetilide-500mcg (Dofetilide 500mcg)

Label for Dofetilide Capsules, 500 mcg (0.5 mg) strength, oral capsules. The label indicates a package size of 60 capsules and is labeled by Granules Pharmaceuticals Inc. It includes storage instructions to keep at 20° to 25°C, a note to dispense the medication guide separately, and references the prescribing information. The label displays the NDC number 70010-026-06 and manufacturing location Chantilly, VA.*

* 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.