Dofetilide Capsule
Product Images NDC 72205-041

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 72205-041). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novadoz Pharmaceuticals Llc, 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

125mcg-60s-cntr (Dofetilide 125mcg 60s Cntr Label)

Dofetilide Capsules 0.125 mg (125 mcg) oral capsules package label displaying a quantity of 60 capsules. Label includes storage instructions and manufacturer information: MSN Laboratories Private Limited, India, and distributor Novadoz Pharmaceuticals LLC, Piscataway, NJ. The label emphasizes pharmacist guidance to dispense the medication guide with the product.*

FDA Label Image

250mcg-60s-cntr (Dofetilide 250mcg 60s Cntr Label)

Label for Dofetilide Capsules 250 mcg (0.25 mg), oral capsules, 60 count. The label states dispensing instructions for pharmacists to provide the accompanying Medication Guide, storage conditions at 15 to 30 degrees Celsius, and moisture protection. The product is manufactured by MSN Laboratories Private Limited, India, and distributed by Novadoz Pharmaceuticals LLC.*

FDA Label Image

500mcg-60s-cntr (Dofetilide 500mcg 60s Cntr Label)

Dofetilide Capsules 500 mcg (0.5 mg) oral capsules, 60 count. Label shows product name, strength, NDC 72205-041-60, and dispensing instructions. Distributed by Novadoz Pharmaceuticals LLC with contact information. Includes storage instructions and note to pharmacist to provide medication guide to patients.*

FDA Label Image

Gualt-eq (Dofetilide Capsules Gault Eq)

A dosing flowchart for oral Dofetilide capsules detailing patient telemetry placement, baseline QTc or QT interval assessment, creatinine clearance calculation formulas by gender, dosage adjustments based on creatinine clearance ranges, post-dose QTc/QT monitoring, and dose continuation or discontinuation criteria based on QTc or QT increases.*

FDA Label Image

Fig01 (Dofetilide Figure 01)

A scatter plot showing the mean change from baseline QTc interval (milliseconds) relative to mean plasma dofetilide concentration (ng/mL) at two different time points: Day 1 and Day 23 (steady state). Data points for Day 1 are represented with open squares and for Day 23 with filled diamonds, with respective trend lines.*

FDA Label Image

Fig02 (Dofetilide Figure 02)

A bar chart comparing change from baseline in QTc at steady state with doses of Dofetilide 125 mcg, 250 mcg, and 500 mcg BID versus placebo. Bars show mean QTc change with 95% confidence intervals, accompanied by dots representing probability of remaining in NSR at 6 months with 95% confidence intervals.*

FDA Label Image

Fig-03 (Dofetilide Figure 03)

A Kaplan-Meier survival curve showing the probability of remaining in NSR (normal sinus rhythm) over 12 months for four groups: placebo and three doses of Dofetilide (125 mcg BID, 250 mcg BID, 500 mcg BID). The graph includes p-values from a log-rank test comparing groups, indicating statistical significance for the 500 mcg BID dose.*

FDA Label Image

Fig-04 (Dofetilide Figure 04)

A Kaplan-Meier survival curve graph showing the probability of remaining in NSR (normal sinus rhythm) over time up to 12 months for Dofetilide oral capsule dosages 125 mcg, 250 mcg, and 500 mcg BID, compared with placebo. The vertical axis represents probability, and the horizontal axis represents time in months. Statistical p-values for each dosage versus placebo are indicated.*

FDA Label Image

Struct (Structure)

Chemical structure of dofetilide, showing its molecular framework including sulfonamide groups, aromatic rings, and amine linkages.*

* 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.