Darifenacin Tablet, Film Coated, Extended Release
Product Images NDC 65862-862

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Darifenacin (NDC 65862-862). 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 (sd) Steady-state Darifenacin Plasma Concentration-time Profiles For Darifenacin Extended-release Tablets 7.5 mg And 15 mg In Healthy Volunteers Including Both Cyp2d6 Ems And Pms* (Darifenacin Fig1)

This appears to be a graph or chart with the Y-axis labeled as "mgod" and the X-axis labeled as "Time Post-Dose (Hours)." However, without additional context or information, it is not clear what the graph is representing or what it is measuring. Therefore, the description is "not-available."*

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Figure 2a. Median Change From Baseline At Weeks 2, 6, 12 For Number Of Urge Incontinence Episodes Per Week (study 1) (Darifenacin Fig2)

The text describes a figure showing the median reduction (and its 95% confidence level) in incontinence episodes per week from baseline in a study. The graph presents data for a placebo and two doses of darifenacin (7.5 mg and 15 mg) over a period of 12 weeks.*

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Figures 2b. Median Change From Baseline At Weeks 2, 6, 12 For Number Of Urge Incontinence Episodes Per Week (study 2) (Darifenacin Fig3)

This is a statistical figure from a study, which includes the number of weeks, the median reduction percentage (with a 95% confidence level) of Incontinence Episodes/week from baseline after taking either the placebo or Darifenacin medication at two different dosages (7.5 mg and 15 mg).*

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Figures 2c. Median Change From Baseline At Weeks 2, 6, 12 For Number Of Urge Incontinence Episodes Per Week (study 3) (Darifenacin Fig4)

This is a specific reference to a figure in a study, indicating Figure 2c from Study 3, with a measurement of time in weeks and two treatments compared: a placebo and Darifenacin 15 mg. The rest of the text is not readable.*

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Package Label-principal Display Panel (7.5 mg (30 Tablet Bottle))

This is a medication description for a drug called Darifenacin. Each tablet contains 0.92 mg, which is equivalent to 7.5 mg of darifenacin. The usual dosage is one tablet per day. This medication comes in extended-release tablets and should be stored at room temperature. The text also includes the drug company's address, code, and warnings not to chew or give it to children. The last line may not be readable and is not available.*

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Package Label-principal Display Panel- 15 mg (30 Tablet Bottle) (Darifenacin Fig6)

This is a medication package for Darifenacin hydrobromide, extended-release tablets. It contains 30 tablets, each of which must be swallowed whole and not chewed, cut, or crushed. The recommended dose of the drug is one tablet per day. The tablet contains 17.85 mg of Darifenacin hydrobromide, equivalent to darifenacin of 15 mg. The package is distributed by Aurobindo Pharma USA and must be stored at room temperature between 20°C to 25°C. It must be kept out of reach of children and protected from light.*

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Chemical Structure (Darifenacin Str)

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