Dofetilide Capsule
Product Images NDC 69452-133

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 69452-133). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bionpharma 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

Chemstructure00001

Chemical structure of Dofetilide depicting its molecular arrangement including aromatic rings, nitrogen atoms, and methanesulfonamide groups.*

FDA Label Image

Graph00005

Flowchart illustrating dosing instructions and safety monitoring for Dofetilide capsules, including patient telemetry setup, QTc or QT interval checks, creatinine clearance calculations, dosing adjustments based on clearance levels, and criteria for dose continuation, decrease, or discontinuation.*

FDA Label Image

Graph0003

A Kaplan-Meier survival curve graph displaying the probability of remaining in NSR (normal sinus rhythm) over 12 months. The graph compares four groups: placebo, 125 mcg BID, 250 mcg BID, and 500 mcg BID doses of Dofetilide. Probability on the y-axis ranges from 0.0 to 1.0, and time in months is on the x-axis. P-values for log rank tests are provided for each dose versus placebo.*

FDA Label Image

Graph0004

A Kaplan-Meier survival curve chart depicting the probability of remaining in NSR (normal sinus rhythm) over time in months. The chart compares four groups: 125 mcg BID Dofetilide, 250 mcg BID Dofetilide, 500 mcg BID Dofetilide, and placebo. The probability decreases over time, with higher doses showing higher probabilities of remaining in NSR. P-values for each dose versus placebo are included.*

FDA Label Image

Figure 1 (Graph001)

A scatter plot with trend lines showing the relationship between mean plasma dofetilide concentration (ng/mL) on the x-axis and mean change from baseline QTc interval (msec) on the y-axis. Data points are differentiated for Day 1 and Day 23 (steady state), illustrating higher QTc changes at Day 1 across concentrations compared to Day 23.*

FDA Label Image

Figure 2 (Graph002)

A bar chart depicting the QTc change from baseline at steady state (in milliseconds) on the left y-axis and the probability of remaining in normal sinus rhythm (NSR) at 6 months (in percentage) on the right y-axis. The x-axis shows four groups: Placebo, Dofetilide 125 mcg BID, Dofetilide 250 mcg BID, and Dofetilide 500 mcg BID. Bars represent QTc change values, while superimposed points with error bars represent the probability of NSR with 95% confidence intervals.*

FDA Label Image

125 Mcg (0.125 mg) 60's Label (Image0001v1)

Dofetilide Capsules 0.125 mg oral dosage form by Bionpharma Inc. The label indicates a package containing 60 capsules. Strength is shown as 125 mcg (0.125 mg). Instructions include pharmacist dispensing information and storage conditions. The label includes a barcode and NDC number 69452-131-17.*

FDA Label Image

250 Mcg (0.25 mg) 60's Label (Image0002v1)

Label for Dofetilide Capsules 0.25 mg oral capsules by Bionpharma Inc. The package contains 60 capsules with dosage instructions and storage information. The label includes a bar code and states 'Rx Only' and 'No Varnish'.*

FDA Label Image

500 Mcg (0.5 mg) 60's Label (Image0003v1)

Label for Dofetilide Capsules 500 mcg (0.5 mg) oral capsules by Bionpharma Inc. The label indicates a package size of 60 capsules, with directions for pharmacists to dispense the enclosed Medication Guide. It also includes dosing and storage information, an NDC number, and a barcode. The label prominently displays "NO VARNISH" on the right side.*

* 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.