Dutasteride Capsule, Liquid Filled
Product Images NDC 71205-278

11 FDA label images from Proficient Rx Lp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 71205-278). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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

71205-278-90 (90ct)

71205-278-90 (90ct)
Label for Dutasteride 0.5 mg liquid-filled capsules, bottle of 90, labeled by Proficient Rx LP and manufactured by Ascent Pharmaceuticals Inc. The label states the capsules are yellow, oblong with clear liquid, printed with 'AT131' in black ink, and includes a warning to see the manufacturer bottle for additional warning information.*
FDA Label Image

Fig1 (Fig1)

Fig1 (Fig1)
A line graph showing the mean change from baseline in AUA-SI (American Urological Association Symptom Index) over 24 months of treatment. The x-axis represents months of treatment (0 to 24), and the y-axis shows mean change from baseline. Two lines compare the effects of Dutasteride versus placebo, with Dutasteride showing a greater decrease in AUA-SI scores over time.*
FDA Label Image

Fig2 (Fig2)

Fig2 (Fig2)
A cumulative incidence plot showing the number of recurrent events over 24 months of treatment for Dutasteride and a placebo group. The x-axis represents months of treatment, and the y-axis shows the count of recurrent patients, with data tables for events and patients at risk for both groups.*
FDA Label Image

Fig3 (Fig3)

Fig3 (Fig3)
A line graph depicting the cumulative percent of patients over 24 months in two groups: placebo and dutasteride. The y-axis shows the percent of patients, and the x-axis represents months of treatment. The placebo group is represented with a dashed line, showing a higher cumulative event rate compared to the solid line for the dutasteride group.*
FDA Label Image

Fig4 (Fig4)

Fig4 (Fig4)
A bar chart showing the mean percent change from baseline over months of treatment (0, 1, 3, 6, 12, 24) comparing Dutasteride and placebo groups. The chart includes sample sizes for each group at each time point, with Dutasteride demonstrating a greater negative change from baseline than placebo across all measured months.*
FDA Label Image

Fig5 (Fig5)

Fig5 (Fig5)
This line graph depicts the mean change from baseline in mL/sec over 24 months of treatment, comparing Dutasteride and placebo groups. The x-axis represents months of treatment, and the y-axis shows mean change from baseline. Dutasteride shows a greater increase over time compared to placebo.*
FDA Label Image

Fig6 (Fig6)

Fig6 (Fig6)
A line graph depicting the mean change from baseline in symptom score over 48 months of treatment for three groups: Dutasteride plus tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg. The x-axis represents months of treatment, and the y-axis shows mean change from baseline in symptom score. Sample sizes for each group are noted below the graph.*
FDA Label Image

Fig7 (Fig7)

Fig7 (Fig7)
A line graph showing mean change from baseline in an unspecified measure over 24 months of treatment. It compares three treatment groups: Dutasteride plus tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg, with sample sizes listed at multiple time points up to 24 months.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure of Dutasteride, showing its steroid-derived core with attached functional groups including a cyclopentanone ring and a trifluoromethyl-substituted aromatic amide moiety.*
FDA Label Image

Tab1 (Tab1)

Tab1 (Tab1)
Table showing the adverse reaction time of onset for Dutasteride versus placebo from 0 to 24 months. It lists percentages of occurrences for impotence, decreased libido, ejaculation disorders, and breast disorders over four time intervals: 0-6, 7-12, 13-18, and 19-24 months.*
FDA Label Image

Tab2 (Tab2)

Tab2 (Tab2)
A data table showing the time of onset for various adverse reactions over four years for the drugs combination, dutasteride, and tamsulosin. It presents the incidence percentages for conditions like ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness, with sample sizes indicated for each period and drug group.*

* 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.