Silodosin Capsule
Product Images NDC 72789-351

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Silodosin (NDC 72789-351). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pd-rx 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

72789351 Label (72789351)

Packaging label for Silodosin 4 mg capsules, containing 30 capsules per package. The label includes dosage instructions, storage conditions, and states it is Rx only. Marketed and packaged by PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK, and manufactured by Aurobindo Pharma Limited, Hyderabad, India. The label features the NDC 72789-351-30 and a barcode.*

FDA Label Image

Figure 1 Mean (±sd) Silodosin Steady State Plasma Concentration-time Profile In Healthy Target-aged Subjects Following Silodosin 8 mg Once Daily With Food (Silodosin Fig1)

A line graph showing silodosin concentration (ng/mL) over time (hours). The plot illustrates a peak concentration around 3 hours post-dose followed by a gradual decline up to 24 hours, with error bars indicating variability at each time point.*

FDA Label Image

Figure 2 Mean Change From Baseline In Ipss Total Score By Treatment Group And Visit In Study 1 (Silodosin Fig2)

A line graph depicting change from baseline in IPSS total score over time, comparing Silodosin 8 mg (solid circles) with placebo (open triangles). The x-axis represents days (B, 3.5, 7, 14, 28, 84/LOCF), and the y-axis represents change from baseline IPSS score, showing greater improvement with Silodosin 8 mg. Statistical significance is noted with p<0.0001.*

FDA Label Image

Figure 3 Mean Change From Baseline In Ipss Total Score By Treatment Group And Visit In Study 2 (Silodosin Fig3)

A line graph showing the change from baseline in IPSS total score over days for Silodosin 8 mg versus placebo groups. The x-axis represents days (Baseline, 3.5, 7, 14, 28, 84/LOCF), and the y-axis represents change in score. The Silodosin group shows a greater decrease in IPSS score compared to placebo, with statistical significance noted at p<0.0001.*

FDA Label Image

Figure 4 Mean Change From Baseline In Qmax (ml/sec) By Treatment Group And Visit In Study 1 (Silodosin Fig4)

Line graph showing change from baseline in Qmax (mL/sec) over 84 days comparing placebo and silodosin 8 mg. The x-axis represents days, and the y-axis shows the change in Qmax. Silodosin 8 mg shows a higher increase than placebo throughout the study period, with significance indicated at day 84/LOCF.*

FDA Label Image

Figure 5 Mean Change From Baseline In Qmax (ml/sec) By Treatment Group And Visit In Study 2 (Silodosin Fig5)

Line graph showing the change from baseline in Qmax (mL/sec) over days for Silodosin 8 mg compared to placebo. The graph plots data at baseline, day 1, 7, 14, 28, and 84 with Silodosin consistently showing a higher increase than placebo. Statistical significance is noted at the end points.*

FDA Label Image

Silodosin Chemical Structure (Silodosin Str)

Chemical structure diagram of silodosin, a human prescription drug active ingredient shown with its molecular configuration, including rings and functional groups.*

* 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.