Dutasteride Capsule
Product Images NDC 65162-750

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 65162-750). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Llc, 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

Dutasteride Structural Formula (Dutasteride Capsules 1)

Chemical structure of Dutasteride, showing its steroidal framework with trifluoromethyl-substituted aromatic ring and amide functional group.*

FDA Label Image

1 (Dutasteride Capsules 2)

A line graph showing the mean change from baseline in AUA-SI over 24 months of treatment comparing Dutasteride and Placebo. The x-axis represents months of treatment (0 to 24), and the y-axis shows the mean change from baseline in AUA-SI. Dutasteride demonstrates a continuous decrease over time, while Placebo shows a smaller change with fluctuations. Sample sizes (n) for each group are noted at different time points.*

FDA Label Image

2 (Dutasteride Capsules 3)

A line chart depicting the cumulative percent of patients over 24 months of treatment comparing Dutasteride and placebo groups. The vertical axis shows percent of patients, while the horizontal axis indicates treatment duration in months. Two lines represent the Dutasteride group and the placebo group, with cumulative event counts and numbers at risk listed below the chart for both groups at various time points.*

FDA Label Image

3 (Dutasteride Capsules 4)

A line graph showing the cumulative percent of patients over 24 months of treatment in two groups: placebo and dutasteride. The y-axis represents percent of patients, ranging from 0 to 6%, and the x-axis represents months of treatment from 0 to 24. The graph includes cumulative event numbers and the number of patients at risk for each group at specified time points.*

FDA Label Image

1 (Dutasteride Capsules 5)

A bar chart showing mean percent change from baseline over 24 months of treatment comparing Dutasteride and placebo groups. The x-axis represents months of treatment (0, 1, 3, 6, 12, 24), and the y-axis shows mean percent change from baseline, with Dutasteride bars consistently showing a greater negative change compared to placebo. Sample sizes for each group at each time point are indicated below the x-axis.*

FDA Label Image

2 (Dutasteride Capsules 6)

A line chart comparing the mean change from baseline in mL/sec over 24 months of treatment between Dutasteride and placebo groups. The x-axis represents months of treatment (0, 1, 3, 6, 12, 18, 24). The y-axis shows mean change from baseline (0 to 2 mL/sec). Dutasteride shows a higher increase over time compared to placebo.*

FDA Label Image

1 (Dutasteride Capsules 7)

Line graph depicting the mean change from baseline in IPSS over 48 months of treatment for three groups: Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg. The x-axis shows months of treatment, and the y-axis shows mean change values. Sample sizes for each group are listed below the graph.*

FDA Label Image

2 (Dutasteride Capsules 8)

A line graph showing mean change from baseline in mL/sec over 24 months of treatment for three groups: Dutasteride plus tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg. The horizontal axis represents months of treatment from 0 to 24, and the vertical axis represents mean change in flow rate from 0 to 3 mL/sec. Dutasteride plus tamsulosin shows the greatest increase, followed by Dutasteride, then Tamsulosin.*

FDA Label Image

1 (Dutasteride Capsules 9)

Dutasteride Capsules 0.5 mg label from Amneal Pharmaceuticals LLC. The label states the product is an oral capsule with a count of 30 capsules. It includes usage warnings advising against use by women or children, storage instructions at 20° to 25°C with permitted excursions, and a notice to not use if the bottle cap seal is broken or missing. The label also shows a barcode and the NDC 65162-750-03.*

* 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.