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

View Photos of Packaging, Regulatory Labels, and Product Appearance

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)

Figure1 (Darifenacin Fig1)
This appears to be a graph or chart showing two lines labeled "75mgod" and "15mgod" with the X-axis labeled as "Time Post-Dose (Hours)" and the Y-axis labeled as "WL g\g\q I 1" and markers at 0, 4, 8, 12, 16, 20, and 24 hours. Without further context or information, it is not possible to provide a useful description.*
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)

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 labeled as "Figure 2a, Study 1" that shows the median reduction in incontinence episodes per week over a period of 12 weeks. The graph shows three different lines representing the placebo and two different doses of Darifenacin (7.5 mg and 15 mg) with their corresponding symbols. The numbers 6 and 12 are also mentioned, potentially indicating time periods or data points on the graph.*
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)

Figures 2b. Median Change From Baseline At Weeks 2, 6, 12 For Number Of Urge Incontinence Episodes Per Week (study 2) (Darifenacin Fig3)
The text describes a chart or figure titled "Figure 2b, Study 2" that displays the median reduction (and 95% Cl) in incontinence episodes/week from baseline over a period of 2, 6, and 12 weeks for three treatments: placebo, darifenacin 7.5 mg, and darifenacin 15 mg.*
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)

Figures 2c. Median Change From Baseline At Weeks 2, 6, 12 For Number Of Urge Incontinence Episodes Per Week (study 3) (Darifenacin Fig4)
This text is a description of a figure in a study labeled as Study 3. The figure is labeled as Figure 2c, and it shows data related to a treatment or intervention over a period of 8 weeks. There are two treatment groups, one labeled as "Placebo" and the other labeled as "Darifenacin 15 mg." The rest of the text is not readable due to incorrect detection, so a thorough description of the study results cannot be provided.*
FDA Label Image

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

FDA Label Image

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

Package Label-principal Display Panel- 15 mg (30 Tablet Bottle) (Darifenacin Fig6)
Each Darifenacin tablet made by Rising Pharma Holdings, Inc. contains 17.85 mg of hydrobromide equivalent to 15 mg of darifenacin. It is an extended-release tablet that should not be chewed, cut, or crushed. The usual dosage is one tablet per day, and it has to be stored at 20° to 25°C (68° to 77°F) protected from light. The packaging contains 30 tablets, and it is distributed by Made In India. The product identification code is NDC16571-768-03.*
FDA Label Image

Chemical Structure (Darifenacin Str)

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