Darifenacin Tablet, Film Coated, Extended Release
Product Images NDC 16571-768

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Darifenacin (NDC 16571-768). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, 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

Figure1 (Darifenacin Fig1)

A line graph showing darifenacin plasma concentration (ng/mL) over 24 hours post-dose for 7.5 mg and 15 mg extended-release oral tablet doses. The graph includes mean concentrations with standard deviation error bars, illustrating higher plasma levels at the 15 mg dose compared to the 7.5 mg dose across the time points.*

FDA Label Image

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 in incontinence episodes per week from baseline over 12 weeks. It compares placebo, Darifenacin 7.5 mg, and Darifenacin 15 mg groups, with the Darifenacin groups showing greater reduction than placebo. The x-axis represents time in weeks (0, 2, 6, 12) and the y-axis reflects median reduction and 95% confidence intervals.*

FDA Label Image

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 titled 'Figure 2b, Study 2' showing median reduction in incontinence episodes per week over 12 weeks. The x-axis represents time in weeks (0, 2, 6, 12), and the y-axis represents median reduction from baseline with 95% confidence intervals. Three data series are shown: placebo, Darifenacin 7.5 mg, and Darifenacin 15 mg, with Darifenacin 15 mg showing the greatest reduction over time.*

FDA Label Image

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

A line graph labeled Figure 2c, Study 3, depicting median reduction and 95% confidence interval in incontinence episodes per week from baseline over a 12-week period. The graph compares Darifenacin 15 mg with placebo, showing greater reduction in incontinence episodes for Darifenacin 15 mg over time.*

FDA Label Image

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

Label for Darifenacin Extended-release Tablets 7.5 mg by Rising Pharma Holdings, Inc. The film-coated, extended-release oral tablets come in a bottle of 30 tablets, Rx only. Storage instructions specify 20°C to 25°C and protection from light. Distributed by Rising Pharma Holdings, East Brunswick, NJ. Manufactured in India.*

FDA Label Image

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

Label for Darifenacin Extended-release Tablets 15 mg by Rising Pharma Holdings, Inc. The label indicates a 30-tablet count and film-coated extended-release tablets. It includes dosage instructions, storage conditions (20° to 25°C), and a caution to keep out of reach of children. The label notes distribution by Rising Pharma Holdings, East Brunswick, NJ, and states the product is made in India.*

FDA Label Image

Chemical Structure (Darifenacin Str)

Chemical structure diagram of darifenacin, showing its molecular framework with characteristic rings and functional groups consistent with the active ingredient darifenacin.*

* 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.