Darifenacin Tablet, Extended Release
Product Images NDC 69097-431

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Darifenacin (NDC 69097-431). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cipla Usa 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

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Chemical structure diagram of Darifenacin Hydrobromide, the active ingredient in Darifenacin extended-release tablets by Cipla USA Inc. The image shows the molecular arrangement of atoms and bonds that define this pharmaceutical compound.*

FDA Label Image

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A line graph depicting plasma concentration of Darifenacin in ng/mL over 24 hours post-dose for 7.5 mg and 15 mg extended-release tablets. The y-axis shows plasma concentration with standard deviation error bars; the x-axis represents time in hours. Data points illustrate higher plasma levels and variability for the 15 mg dose compared to 7.5 mg dose.*

FDA Label Image

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A line graph titled 'Figure 2a, Study 1' showing mean reduction in a measured variable as percent change from baseline over 12 weeks. The x-axis represents time in weeks, and the y-axis shows the percent reduction in urinary incontinence episodes per week. Three groups are plotted: Placebo (open circles), Darifenacin 7.5 mg (gray squares), and Darifenacin 15 mg (black squares), with both Darifenacin dosages showing greater reduction than placebo over time.*

FDA Label Image

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A line graph showing median reduction in incontinence episodes per week from baseline over time (weeks) for placebo, Darifenacin 7.5 mg, and Darifenacin 15 mg. The graph plots data points at baseline, 2, 6, and 12 weeks, indicating greater reduction in episodes with higher doses of Darifenacin compared to placebo.*

FDA Label Image

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A line graph comparing the median reduction in incontinence episodes per week over 12 weeks between Placebo and Darifenacin 15 mg groups. The y-axis shows median reduction from baseline in counts with 95% confidence intervals, and the x-axis represents time in weeks. Darifenacin 15 mg shows a greater decrease in episodes than placebo throughout the study duration.*

FDA Label Image

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Label for Darifenacin Extended Release Tablets 7.5 mg by Cipla USA Inc. The label states the NDC 69097-431-02 and that the package contains 30 tablets. It highlights the 7.5 mg strength and includes storage instructions, dosing information, and manufacturer details. The label also features a barcode and space designated for batch overprinting including serial number, expiry, and lot information.*

FDA Label Image

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Label for Darifenacin Extended Release Tablets 15 mg by Cipla USA Inc. The label indicates a 30 tablet count and includes dosage information, storage instructions, and manufacturing details. It states the product is a prescription drug with a barcode and space for batch information including serial number, expiry, and lot.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.