Dofetilide Capsule
Product Images NDC 72603-130

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 72603-130). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rxllc, 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

Dofetilide-figure1 (Dofetilide Figure1)

Dofetilide-figure1 (Dofetilide Figure1)
This is a chart displaying the mean change in QTc from baseline measured in milliseconds (msec) on day 1 and less than day 23 at steady state. There is a corresponding graph that shows the mean plasma concentration of Dofetilide (measured in ng/mL) over time.*
FDA Label Image

Dofetilide-figure2 (Dofetilide Figure2)

FDA Label Image

Dofetilide-figure3 (Dofetilide Figure3)

Dofetilide-figure3 (Dofetilide Figure3)
This is a graph showing the probability of remaining in NSR (normal sinus rhythm) over time, with different doses of Dofetilide and a placebo. The x-axis represents time in months and the y-axis represents the probability of remaining in NSR. The graph is accompanied by p-values obtained from the Log Rank Test for different doses of Dofetilide, including 125 meg BID (p=0.21), 250 mcg BID (p=0.10), and 500 mcg BID (p<0.001).*
FDA Label Image

Dofetilide-figure4 (Dofetilide Figure4)

Dofetilide-figure4 (Dofetilide Figure4)
This appears to be a chart showing the probability of remaining in NSR at different medication dosages and frequencies. It also shows the p-value from a Log Rank Test for each dosage. The medication being discussed is Dofetilide at dosages of 125mcg, 250mcg, and 500mcg taken twice daily. The chart displays the probability of remaining in NSR at different time intervals (in months) for each dosage level.*
FDA Label Image

Dofetilide-figure5 (Dofetilide Figure5)

Dofetilide-figure5 (Dofetilide Figure5)
This document contains medical guidelines for the use of a drug called Dofetide and focuses on determining an appropriate dosage based on a patient's weight and renal function. It cautions against use in certain circumstances, such as with low clearance rates or if the patient displays specific cardiac issues. It also provides instructions for post-dosage adjustments and how to discontinue the drug if necessary.*
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Dofetilide-structure (Dofetilide Structure)

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Spl-dofetilide-label-125mcg (Spl Dofetilide Label 125mcg)

Spl-dofetilide-label-125mcg (Spl Dofetilide Label 125mcg)
This is a description of a medication containing dofetilide, which is available in hard gelatin capsules. The capsules come in 125 mcg (0.125 mg) USP Controlled Room Temperature, and are manufactured by Sun Pharmaceutical Industries Limited in India. It is dispensed by pharmacists in tight containers (USP) and should be kept away from moisture and humidity. The usual dosage and prescribing information is included in the package, with a guide for each patient provided separately. The medication is available in bottles containing 60 capsules, and can be ordered through the Northstar Rx LLC website or by calling 1-800-206-7821.*
FDA Label Image

Spl-dofetilide-label-250mcg (Spl Dofetilide Label 250mcg)

Spl-dofetilide-label-250mcg (Spl Dofetilide Label 250mcg)
Each hard gelatin capsule contains 250 mcg (0.25 mg) dose of dofeilide, USP. It is manufactured by Sun Pharmaceutical Industries Limited and dispensed in tight containers. The usual dosage information can be found in the accompanying prescribing information. It should be stored at a controlled room temperature between 20°-25°C (68°-77°F) and in a dry place. Pharmacists are advised to provide the medication with a guide to each patient. This product comes with 60 capsules and can be purchased on the Northstar Healthcare Holdings Ltd website or by calling 1-800-206-7821. The LOT is ARAK#A and it expires on MMIYYYY. The product is not available in non-English characters.*
FDA Label Image

Spl-dofetilide-label-500mcg (Spl Dofetilide Label 500mcg)

Spl-dofetilide-label-500mcg (Spl Dofetilide Label 500mcg)
This is a medication manufactured by Sun Pharmaceutical Industries for Northstar Rx LLC. It is a 500 mcg (0.5 mg) dofetlide hard capsule with dosage instructions provided on the accompanying Prescribing Information sheet. The medication should be stored in a tight container at a temperature of 20° to 25°C (68° to 77°F) with controlled room temperature of 15° and 30°C (59° and 86°F). The medication should be kept away from moisture and humidity. The packaging contains 60 capsules and a patient guide is provided. The product was manufactured in India, and the lot number is AAAKEEA with an expiration date of MMIYYYY.*

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