Darifenacin
Product Images NDC 52605-067

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Darifenacin (NDC 52605-067). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Polygen Pharmaceuticals 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

Image (Darifenacin Fig01)

A line graph illustrating Darifenacin plasma concentration (ng/mL) mean and standard deviation over 24 hours post-dose. Two dosage groups are shown: 7.5 mg once daily (open circles) and 15 mg once daily (filled circles). The graph depicts the time course of Darifenacin levels in plasma for both dosages.*

FDA Label Image

Image (Darifenacin Fig02)

A line graph from Study 1 showing median reduction in urinary incontinence episodes per week over 12 weeks. The x-axis represents time in weeks (0, 2, 6, 12), and the y-axis shows median reduction from baseline with 95% confidence intervals. Data lines compare placebo (open circle), Darifenacin 7.5 mg (triangle), and Darifenacin 15 mg (square), illustrating decreasing incontinence episodes over time with higher reductions for Darifenacin doses compared to placebo.*

FDA Label Image

Image (Darifenacin Fig03)

Line graph titled Figure 2b, Study 2, showing median reduction in urinary incontinence episodes from baseline over 12 weeks. It compares placebo (open circles, dashed line) with Darifenacin 7.5 mg (triangles, solid line) and Darifenacin 15 mg (squares, solid line). Reduction is shown as percent decrease on the y-axis and time in weeks on the x-axis, with Darifenacin 15 mg showing greatest reduction.*

FDA Label Image

Image (Darifenacin Fig04)

A line graph titled 'Figure 2c, Study 3' illustrating median reduction in incontinence episodes per week from baseline over 12 weeks. The y-axis shows median reduction with 95% confidence intervals, while the x-axis shows time in weeks (0, 2, 6, 12). Two lines compare placebo (open circles, dashed line) and Darifenacin 15 mg (solid squares, solid line), showing greater reduction with Darifenacin across the study period.*

FDA Label Image

Image (Darifenacin Label 15mg 1000)

Darifenacin Extended-release Tablets 15 mg label from PolyGen Pharmaceuticals Inc. The label includes the NDC 52605-068-10, package size of 1000 tablets, and states 'Rx Only'. It instructs pharmacists to dispense patient information separately and provides storage and handling directions.*

FDA Label Image

Image (Darifenacin Label 15mg 30)

Darifenacin 15 mg extended-release tablets label by PolyGen Pharmaceuticals Inc. The label indicates each tablet contains 15 mg of darifenacin. It includes a barcode, lot and expiration date fields, quantity of 30 tablets, prescription-only status, dosage instructions, storage conditions, and a warning to keep out of reach of children.*

FDA Label Image

Image (Darifenacin Label 15mg 90)

Darifenacin extended-release tablets 15 mg, packaged with 90 tablets per container. The label includes a barcode, lot and expiration date fields, usage instructions, and storage conditions. Manufactured and distributed by PolyGen Pharmaceuticals Inc., Edgewood, NY. The label specifies the active ingredient quantity as 17.858 mg darifenacin hydrobromide, equivalent to 15 mg darifenacin.*

FDA Label Image

Image (Darifenacin Label 7 5mg 1000)

Darifenacin Extended-release Tablets 7.5 mg label showing key information including dosage strength, quantity of 1000 tablets, and manufacturer PolyGen Pharmaceuticals Inc. The label includes barcode, lot and expiration fields, pharmacist dispensing instructions, storage conditions, and usage warnings.*

FDA Label Image

Image (Darifenacin Label 7 5mg 90)

Label for Darifenacin extended-release tablets 7.5 mg by PolyGen Pharmaceuticals Inc. The label includes a barcode, lot and expiration date fields, directions for pharmacist dispensing, quantity of 90 tablets, and storage instructions. It states the tablets contain 8.929 mg darifenacin hydrobromide equivalent to 7.5 mg darifenacin and are prescription only.*

FDA Label Image

Image (Darifenacin Str)

Chemical structure of darifenacin, showing the specific arrangement of rings, bonds, and functional groups that define the molecule's composition.*

* 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.