Darifenacin Tablet, Film Coated, Extended Release
Product Images NDC 65862-861

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Darifenacin (NDC 65862-861). 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.

FDA Label Image

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)

A line graph illustrating mean darifenacin plasma concentration (ng/mL) with standard deviation over 24 hours post-dose, comparing 7.5 mg and 15 mg extended-release oral doses. The 15 mg dose shows higher plasma concentration levels throughout the time points measured.*

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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)

A line graph titled 'Figure 2a, Study 1' showing median reduction and 95% confidence intervals in incontinence episodes per week from baseline over 12 weeks. The x-axis denotes time in weeks (0, 2, 6, 12), and the y-axis shows median reduction values. Three lines represent placebo (open circles), Darifenacin 7.5 mg (triangles), and Darifenacin 15 mg (squares), demonstrating greater reduction in episodes with higher Darifenacin dosage compared to placebo.*

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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)

A line graph illustrating median reduction and 95% confidence intervals in incontinence episodes per week from baseline over 12 weeks. The graph compares placebo, Darifenacin 7.5 mg, and Darifenacin 15 mg groups, showing reductions at 2, 6, and 12 weeks with values decreasing most in the Darifenacin 15 mg group.*

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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)

Line graph titled 'Figure 2c, Study 3' showing median reduction in incontinence episodes per week from baseline over time in weeks (0, 2, 6, 12). Two lines represent Placebo and Darifenacin 15 mg, with Darifenacin showing greater reduction in episodes. Error bars indicate 95% confidence intervals.*

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

Darifenacin Extended-release Tablets 7.5 mg film-coated oral tablets, distributed by Aurobindo Pharma USA, Inc, shown on a carton label. The label includes dosage form, strength, storage instructions, and manufacturer information. The package contains 30 tablets and is labeled for prescription use only.*

FDA Label Image

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

Label for Darifenacin Extended-release Tablets 15 mg, film-coated oral tablets. The label includes dosage instructions and storage information. It shows a quantity of 30 tablets and identifies Aurobindo Pharma Limited as the labeler, with distribution by Aurobindo Pharma USA, Inc. The product is made in India, and the label features the NDC 65862-862-30 and a barcode.*

FDA Label Image

Chemical Structure (Darifenacin Str)

Chemical structure of Darifenacin, showing its molecular configuration including aromatic rings, a piperidine ring, and key functional groups relevant to the compound.*

* 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.