Dofetilide Capsule
Product Images NDC 16729-490

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dofetilide (NDC 16729-490). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare, 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

Chemical Structure (Dofetilide 01)

FDA Label Image

Figure 1 (Dofetilide 02)

Figure 1 (Dofetilide 02)
The text displays the mean change from baseline QTc in msec on day 1 and day 23. Also, it shows the mean plasma Dofetilide concentration in ng/mL.*
FDA Label Image

Figure 2 (Dofetilide 03)

FDA Label Image

Figure 3 (Dofetilide 04)

FDA Label Image

Figure 4 (Dofetilide 05)

Figure 4 (Dofetilide 05)
This text appears to be a set of medication doses for Dofetilide with varying strengths. Additionally, there is a reference to p-values and a Log Rank Test with associated results. The final line seems to indicate a timeline.*
FDA Label Image

Flow Chart (Dofetilide 06)

Flow Chart (Dofetilide 06)
This appears to be a medical document with instructions regarding administering the drug Dofetilide to patients. The text advises placing the patient on telemetry, checking baseline QTC, and calculating creatinine clearance. If Creatinine clearance is less than 20 mL/min, Dofetilide is contraindicated. Depending on the level of Creatinine Clearance, the text instructs the amount of Dofetilide to be given and how often. It also advises performing a Tc check after the first dose and if there is a greater than 15% increase in QTc, decrease the dose or discontinue its use. Finally, the text advises that if there is a 500 msec increase in QTC after the second dose, Dofetilide should be discontinued.*
FDA Label Image

Principal Display Panel (0.125 mg Capsule Bottle Label)

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Principal Display Panel (0.25 mg Capsule Bottle Label)

Principal Display Panel (0.25 mg Capsule Bottle Label)
This is information on a medication called "Emnimne Capsules". The text provides details on the manufacturer, dosage instructions, and storage requirements. Additionally, it mentions that the medication is controlled and dispensed by a pharmacist. Overall, this text could be useful for individuals looking to learn more about this specific medication.*
FDA Label Image

Principal Display Panel (0.5 mg Capsule Bottle Label)

Principal Display Panel (0.5 mg Capsule Bottle Label)
This is the label of medication called "Dofetilide" manufactured by Accord Healthcare, Inc. Each container contains 80 capsules with 0.5 mg strength. The usual dosage should be checked on the accompanying medication guide. The medicine should be stored between 15°C to 30°C. The manufacturer is Infas Pharmaceuticals Limited from India. There are some references to the controlled room temperature, DEA Dula ki courtiers, and NDC number (16729-492) mentioned, but their relevance is unclear.*

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