Silodosin Capsule
Product Images NDC 59651-095

8 FDA label images from Aurobindo Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Silodosin (NDC 59651-095). 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.

Product Images & Figures Index

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)

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 depicting silodosin concentration in blood plasma over time. The y-axis shows silodosin concentration in ng/mL, ranging from 0 to 80, and the x-axis shows time in hours from 0 to 24. The graph includes data points connected by a line with error bars at each time point, illustrating the changes in silodosin concentration over a 24-hour period.*
FDA Label Image

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

Figure 2 Mean Change From Baseline In Ipss Total Score By Treatment Group And Visit In Study 1 (Silodosin Fig2)
A line graph showing change from baseline in IPSS Total Score over days comparing Silodosin 8 mg capsules with placebo. The x-axis represents days, including baseline, 3.5, 7, 14, 28, and 84, and the y-axis shows the change from baseline. Silodosin 8 mg shows a greater reduction in score over time compared to placebo, with statistical significance indicated.*
FDA Label Image

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

Figure 3 Mean Change From Baseline In Ipss Total Score By Treatment Group And Visit In Study 2 (Silodosin Fig3)
A line graph showing change from baseline in IPSS Total Score over days in two groups: placebo (triangle markers) and Silodosin 8 mg (circle markers). Silodosin shows a greater decrease in score, indicating more improvement, with statistical significance noted (p<0.0001) compared to placebo by day 84/LOCF.*
FDA Label Image

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

Figure 4 Mean Change From Baseline In Qmax (ml/sec) By Treatment Group And Visit In Study 1 (Silodosin Fig4)
A line graph depicting change from baseline in Qmax (mL/sec) over days for Silodosin 8 mg compared to placebo. The x-axis shows time points from baseline through day 84/LOCF, while the y-axis measures change in Qmax. Silodosin 8 mg shows a higher increase over time with statistically significant differences noted (p<0.05).*
FDA Label Image

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

Figure 5 Mean Change From Baseline In Qmax (ml/sec) By Treatment Group And Visit In Study 2 (Silodosin Fig5)
A line graph showing change from baseline in Qmax (mL/sec) over time (days) comparing Silodosin 8 mg (solid circles) and placebo (open triangles). Silodosin maintains a higher increase in Qmax throughout the study period up to day 84/LOCF. Statistical significance is indicated at certain points on the graph.*
FDA Label Image

Package Label-principal Display Panel (4 mg (30 Capsules Bottle))

Package Label-principal Display Panel (4 mg (30 Capsules Bottle))
Silodosin Capsules 4 mg label from Aurobindo Pharma Limited. The label specifies the dosage as 4 mg per capsule, with 30 capsules in the package. It includes storage instructions at 20° to 25°C (68° to 77°F) and notes the product is distributed by Aurobindo Pharma USA, Inc. Made in India, with Rx only designation and an NDC number 59651-095-30.*
FDA Label Image

Package Label-principal Display Panel (8 mg (30 Capsules Bottle))

Package Label-principal Display Panel (8 mg (30 Capsules Bottle))
Label for Silodosin Capsules 8 mg, oral dosage form, containing 30 capsules. The label indicates a prescription drug manufactured by Aurobindo Pharma Limited and distributed by Aurobindo Pharma USA, Inc. It includes storage instructions and dosage information, stating each capsule contains 8 mg of Silodosin.*
FDA Label Image

Silodosin Chemical Structure (Silodosin Str)

Silodosin Chemical Structure (Silodosin Str)
Chemical structure of silodosin, showing its molecular composition with several aromatic rings, oxygen, nitrogen, and trifluoromethyl 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.