Dofetilide Capsule
Product Images NDC 59651-119

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 59651-119). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Figure 1: Mean Qtc-concentration Relation Ship In Young Volunteers Over 24 Days (Dofetilide Fig1)

The text describes a graphic representation of a study on the relationship between mean QTc concentration and Dofetilide concentration in young volunteers, over a period of 24 days. The graph shows the mean change from the baseline in QTc (in milliseconds) over increasing plasma Dofetilide concentrations (in ng/mL) up to day 23, which is the steady-state day.*

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Figure 2: Relationship Between Dofetilide Dose, Qtc Increase And Maintenance Of Nsr (Dofetilide Fig2)

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Figure 3: Maintenance Of Normal Sinus Rhythm, Dofetilide Regimen Vs. Placebo (study 1) (Dofetilide Fig3)

This is a statistical table analyzing the probability of remaining in normal sinus rhythm (NSR) at different dosages (125mg, 250mg, and 500mg taken twice daily). The p-values obtained from the Log Rank Test suggest that the likelihood of remaining in NSR is significantly higher for those taking the higher doses, with the 500mg BID showing the most significant difference. The table plots the time (in months) against the probability of remaining in NSR.*

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Figure 4: Maintenance Of Normal Sinus Rhythm, Dofetilide Regimen Vs. Placebo (study 2) (Dofetilide Fig4)

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Figure 5 (Dofetilide Fig5)

The text looks like excerpts from a medical report containing various medical terms such as GTc, WQTe, serum creatine, Creatne Clearance, and QT interval. It provides instructions for checking Baseline GTc or GT, adjusting post-dose, and calculating Creatine Clearance. There are also contraindications for T Clr 2 <20 mmin. However, the text has inconsistencies and incomplete information that make understanding the context difficult.*

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Dofetilide-fig6 (Dofetilide Fig6)

This is a description for Dofetilide Capsules, which comes in a bottle with a National Drug Code 59651-118-60. Each capsule contains 125 mcg of Dofetiide USP. These capsules are distributed by Aurobindo Pharma USA, Inc. in East Windsor. The recommended dosage should be determined by a doctor, and instructions should be carefully followed. The capsules should be stored at 20° to 25°C (68° to 77°F) to protect from moisture and humidity, and dispensed in tight containers. The provided text includes information about how to dispense medication, but the original details are not available due to errors. The capsules are manufactured in India.*

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Dofetilide-fig7 (Dofetilide Fig7)

Dofetilide Capsules are a medicine prescribed only by a certified healthcare professional. A medication guide is provided to each patient along with the drug. The capsule is distributed by Aurobindo Pharma USA, Inc. and each capsule contains Dofetllide USP 250 meg (0.25 mg). The usual dosage should be as per the accompanying prescribing information. The medicine is packed in tight containers and should be stored at a temperature between 20°C to 25°C, which is approximately 68°F to 77°F. The product needs to be protected from moisture and humidity. The Code for the medicine is AP/DRUGS/04/2016.*

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Dofetilide-fig8 (Dofetilide Fig8)

Dofetilide Capsules is a prescription drug that is used as per the accompanying prescribing information. The product is manufactured in India and distributed by Aurobindo Pharma USA, Inc. The package contains 60 capsules with each capsule having 500mcg of Dofetilide USP. It is recommended to dispense the drug with a medication guide provided separately to each patient. The product should be stored in tight containers at 20 to 25°C (68 to 77°F) and protected from moisture and humidity.*

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Chemcial Structure (Dofetilide Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.