Dutasteride Capsule, Liquid Filled
Product Images NDC 42806-549

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 42806-549). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Epic Pharma, 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

Edut02-00 (Edut02 00)

Label for Dutasteride Capsules 0.5 mg, oral liquid-filled capsules. The label includes dosage instructions, warnings, and storage information. Distributed by Epic Pharma, LLC in Laurelton, NY, and manufactured by Hunanwell PuraCap Pharmaceutical in Wuhan, China. The package contains 90 capsules with NDC 42806-549-09.*

FDA Label Image

Figure-1 (Figure 1)

A line graph comparing mean change from baseline in AUASI scores over 24 months of treatment for Dutasteride and Placebo groups. The X-axis shows months of treatment from 0 to 24, and the Y-axis shows mean change from baseline. Dutasteride shows a greater decrease over time compared to Placebo, with sample sizes near 2,122 for both groups at each time point.*

FDA Label Image

Figure-2 (Figure 2)

A line graph comparing cumulative events over 24 months of treatment between a placebo group and a dutasteride group. The y-axis represents the percent of patients, and the x-axis shows months of treatment. The graph includes numerical data on cumulative events and number of patients at risk for each time point in both groups.*

FDA Label Image

Figure-3 (Figure 3)

A line graph showing the cumulative percent of patients over 24 months of treatment in placebo and dutasteride groups. The x-axis represents months of treatment, and the y-axis shows the percent of patients. The graph includes cumulative event counts and number of patients at risk for each group at intervals (0, 6, 12, 18, and 24 months).*

FDA Label Image

Figure-4 (Figure 4)

Bar chart comparing mean percent change from baseline over time (0, 1, 3, 6, 12, and 24 months) between placebo and Dutasteride treatment groups. The x-axis shows months of treatment with sample sizes noted below each time point. The y-axis shows mean percent change from baseline, with values decreasing to around -25% at 24 months for Dutasteride and less reduction for placebo.*

FDA Label Image

Figure-5 (Figure 5)

A line graph depicting mean change from baseline in mL/sec over months of treatment (0, 1, 3, 6, 12, 18, 24) comparing placebo and Dutasteride groups. The graph shows two lines with placebo indicated by filled squares and Dutasteride by open circles, illustrating different response trends over 24 months with sample sizes noted at each time point.*

FDA Label Image

Figure-6 (Figure 6)

A line graph depicting the mean change from baseline in IPSS (International Prostate Symptom Score) over 48 months of treatment. The graph compares three groups: Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg, with sample sizes around 1,575 to 1,592 for each group at each time point.*

FDA Label Image

Figure-7 (Figure 7)

A line graph depicting mean change from baseline (in mL/sec) over 24 months of treatment with Dutasteride plus tamsulosin, Dutasteride 0.5 mg, and tamsulosin 0.4 mg. The x-axis shows treatment duration in months, and the y-axis shows mean change from baseline in mL/sec. Data points for each group are displayed with distinct markers and the corresponding sample sizes (n) are noted below for time points 6, 12, 18, and 24 months.*

FDA Label Image

Structural-formula (Image 01)

Chemical structure of Dutasteride. The diagram shows the molecular structure with labeled atoms, including hydrogen (H), oxygen (O), nitrogen (N), and trifluoromethyl groups (CF3). It includes the steroid backbone and attached functional groups characteristic of Dutasteride.*

* 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.