Flowchart.jpg (Flowchart)
Dofetilide Capsule
Product Images NDC 76282-756
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 76282-756). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Exelan 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.
Fig_1.jpg (Fig 1)
This text appears to provide data on the mean change from baseline QTc in milliseconds on Day 1 and Day 23 (Steady State) correlating with the mean plasma dofetilide concentration in nanograms per milliliter. This information may be used to evaluate the relationship between dofetilide concentration and QTc change over time during a study or clinical trial.*
Fig_2.jpg (Fig 2)
Fig_3.jpg (Fig 3)
This text appears to be showing data related to a study or clinical trial involving different dosages of a medication called Dofetilide. The study includes various dosage levels (125mcg, 250mcg, and 500mcg) administered twice a day (BID). The text also mentions the p-value results from a Log Rank Test for each dosage. Additionally, there is a mention of a placebo group. The data seems to include time points at 6, 9, and 12 months. This information might be useful for evaluating the efficacy or outcomes of Dofetilide at different dosages over time compared to a placebo.*
Fig_4.jpg (Fig 4)
This is a clinical study evaluating the effects of different doses of Dofetilide in patients. The study includes three different doses (125meg, 250meg, and 500meg) administered twice daily. The p-values are reported for each dose from the log-rank test, indicating statistical significance in the outcomes. The time (in months) is plotted on the x-axis, suggesting a survival or time-to-event analysis was carried out in the study.*
Structure.jpg (Structure)
0.125mg.jpg (Dofetilide 125mcg)
This text contains information about a medication called Dofetilide in capsule form. It includes details for pharmacists on dispensing the medication guide to each patient, dosage instructions, storage recommendations, and manufacturing details by Granules Pharmaceuticals Inc. The medication is to be kept away from moisture and humidity, stored at room temperature, and dispensed as per the available medication guide.*
0.25mg.jpg (Dofetilide 250mcg)
A description for a medication named Dofetilide in capsule form. It is available in a 250mg dosage. The text mentions the necessity to protect the capsules from moisture and humidity. The medication should be dispensed to patients separately. The manufacturer is Ganujes Pharmaceuticals Inc. The text provides pharmacist handling instructions and contact information, including an address in Boca Raton, FL.*
0.5mg.jpg (Dofetilide 500mcg)
Each capsule of this medication contains 500 mcg (0.5 mg) of dofetilide USP. It is recommended to refer to the accompanying prescribing information for the usual dosage. The medication should be stored in a container that is not child-resistant according to the USP guidelines and should be protected from moisture and humidity. Dispensing the medication separately to each patient is advised. This prescription is for 60 capsules distributed by EKELAN Pharmaceuticals.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
