Dutasteride Capsule, Liquid Filled
Product Images NDC 68071-4821

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 68071-4821). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare 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

Pdp (68071 4821 9)

Label for Dutasteride 0.5 mg capsules from NuCare Pharmaceuticals, Inc. The label indicates a quantity of 90 capsules, marked Rx Only. It includes the NDC 68071-4821-9 and notes to take every 12 hours. Storage instructions specify a controlled temperature of 68-77°F. Additional manufacturing and lot details are present, along with a warning to keep out of reach of children.*

FDA Label Image

Fig1 (Fig1)

A line graph showing the mean change from baseline in AUASI over 24 months of treatment comparing Dutasteride and placebo. The x-axis represents months of treatment (0 to 24), and the y-axis shows mean change from baseline in AUASI, with Dutasteride showing a greater decrease over time compared to placebo.*

FDA Label Image

Fig2 (Fig2)

A line chart comparing the cumulative retention of patients over 24 months of treatment between a placebo group and a Dutasteride group. The x-axis represents months of treatment, while the y-axis shows retention of patients. Data tables below the graph indicate the number of events and patients at risk for each group at different time points.*

FDA Label Image

Fig3 (Fig3)

A line graph depicting the cumulative percent of patients experiencing events over 24 months of treatment, comparing a placebo group and a dutasteride group. The x-axis represents months of treatment, and the y-axis represents percent of patients. Below the graph, a table shows the number of events, cumulative events, and patients at risk for each group at multiple time points.*

FDA Label Image

Fig4 (Fig4)

A bar chart showing the mean percent change from baseline over months of treatment for Dutasteride versus placebo. The chart includes data points at 0, 1, 3, 6, 12, and 24 months, comparing the effect of Dutasteride and placebo on the measured outcome.*

FDA Label Image

Fig5 (Fig5)

A line graph depicting the mean change from baseline over 24 months of treatment for Dutasteride versus placebo. The x-axis represents months of treatment from 0 to 24, and the y-axis shows the mean change from baseline in ml/sec ranging from 0 to 2. Two data lines compare the treatment effects, with sample sizes (n) noted for each time point.*

FDA Label Image

Fig6 (Fig6)

A line graph showing the mean change from baseline in PSA levels over 48 months of treatment comparing Dutasteride plus Tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg. The x-axis represents months of treatment, and the y-axis shows the mean change from baseline in PSA (ng/mL). Sample sizes at various time points are indicated below the graph.*

FDA Label Image

Fig7 (Fig7)

A line graph showing the mean change from baseline in red blood cell (RBC) levels over 24 months of treatment for three groups: Dutasteride plus tamsulosin, Dutasteride 0.5 mg alone, and Tamsulosin 0.4 mg alone. The x-axis represents months of treatment up to 24, while the y-axis shows mean change from baseline in RBC levels.*

FDA Label Image

Structure (Structure)

Chemical structure of Dutasteride showing its steroid backbone and trifluoromethyl-substituted phenyl ring, consistent with the active ingredient Dutasteride.*

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Tab1 (Tab1)

Data table presenting adverse reaction time of onset for dutasteride and placebo groups across different time periods (0-6, 7-12, 13-18, 19-24 months). It shows percentages of patients experiencing impotence, decreased libido, ejaculation disorders, and breast disorders for both dutasteride and placebo groups over these intervals.*

FDA Label Image

Tab2 (Tab2)

A data table presenting the time of onset for various adverse reactions associated with Dutasteride, Tamsulosin, and their combination over a span of four years. The table lists adverse reactions such as ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness with corresponding percentages for each medication group during specific time intervals from 0 to 6 months up to year 4.*

* 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.