Dofetilide Capsule
Product Images NDC 47335-062

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 47335-062). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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.

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Dofetilide-figure1 (Dofetilide Figure1)

The text describes a chart that shows the mean change in QTc (a measure of heart rhythm) in milliseconds from the beginning of the study (Baseline) over time (up to Day 23) while taking a medication called Dofetilide. The chart also shows the mean plasma concentration of Dofetilide in ng/mL.*

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Dofetilide-figure2 (Dofetilide Figure2)

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Dofetilide-figure3 (Dofetilide Figure3)

This text presents data on the probability of remaining in normal sinus rhythm for different doses of Dofetilide compared to placebo. The text includes a graph with the probability scale from 0 to 1, p-values for the different doses, a Log Rank Test reference and a time scale in months.*

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Dofetilide-figure4 (Dofetilide Figure4)

This appears to be graphically represented medical data that displays the probability of remaining in normal sinus rhythm (NSR) over time for patients taking different doses of a medication called Dofetilide. The doses are represented as 500mcg BID, 250mcg BID, and 125mcg BID, respectively. The p-value of the Log Rank Test is also provided for each dose. The time frame of the study appears to be in months.*

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Dofetilide-figure5 (Dofetilide Figure5)

The text is providing instructions on the use of the medication Dofetilide for the treatment of certain heart conditions. It emphasizes the importance of checking the patient's kidney function and assessing their risk for abnormal heart rhythms before starting treatment. The text also provides dosing instructions and guidance for adjusting the dose based on changes in the patient's heart function.*

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Dofetilide-label1 (Dofetilide Label1)

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Dofetilide-label2 (Dofetilide Label2)

Each gelatin capsule contains 250 mcg (0.25 mg) dofetide, USP. This medication is dispensed in tight containers and stored between 20°-25°C (68°-77°F). Excursions permitted between -15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. The pharmacist should dispense with a medication guide to each patient. It must be protected from moisture and humidity. The medication guide is available online at https://www.sunpharma.com/usa/products. The manufacturer is Sun Pharmaceutical Industries Limited, located in India.*

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Dofetilide-label3 (Dofetilide Label3)

Each capsule of this medication contains 500mg of Dofetilide, USP. The usual dosage should be obtained from the accompanying Prescription Information. It is recommended to keep the medication in a tight container and protect it from moisture and humidity. The medication guide can be found at the website provided by the distributor, Sun Pharmaceutical Industries, Inc. It should be dispensed with the medication to each patient. These capsules are manufactured by Sun Pharmaceutical Industries Limited, located in India.*

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Dofetilide-showbox1 (Dofetilide Showbox1)

Dofetilide capsules in 125mcg dosage, containing 125mg of dofetilide, USP per hard gelatin capsule are available in a pack of 40 capsules there is no child-resistant feature. These capsules should be stored at a temperature of 20° to 25°C (66° to 77°F) and protected from moisture and humidity. Further details can be obtained from the accompanying Prescribing Information and Medication Guide available online. This product is for institutional use only and pharmacists should dispense it with a Medication Guide for each patient. The product is distributed by Sun Pharmaceutical Industries, Inc. and manufactured by Sun Pharmaceutical Industries Limited in India.*

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Dofetilide-showbox2 (Dofetilide Showbox2)

This is a medication called Dofetilide Capsules, identified by the National Drug Code (NDC) 47335-062-79. Each capsule contains 250mcg (0.25mg) of the active ingredient, dofetilide USP. It is advised to dispense this medication with a medication guide to each patient. It comes in a package of 40 capsules (4 X 10 Unit-dose) for institutional use only. The storing temperature of this medication is between 20°C and 25°C (68 to 77°F). This medication guide is available at www.sunpharma.com/usa/products. It is distributed by Sun Pharmaceutical Industries, Inc. located in Cranbury, NJ, and manufactured by Sun Pharmaceutical Industries Limited from India.*

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Dofetilide-showbox3 (Dofetilide Showbox3)

Dofetilide Capsules are available in a pack of 40 institutional use-only capsules containing 500 mcg of dofetilide USP per unit dose. The medication guide is dispensed with each capsule for the pharmacist to provide to the patient. The capsules are not child-resistant, and should be stored at room temperature between 20° to 25°C (66° to 77°F) with limited excursions to 15° and 30°C (59° and 86°F). The medication should be protected from moisture and humidity. More information about the medication can be found at the manufacturer's website.*

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Dofetilide-structure (Dofetilide Structure)

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