Dutasteride Capsule, Liquid Filled
Product Images NDC 63629-1222

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 63629-1222). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bryant Ranch Prepack, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Fig1 (Fig1)

A line graph titled 'AUA-SI Score Change from Baseline (Randomized, Double-blind, Placebo-Controlled Trials Pooled)' showing mean change from baseline in AUA-SI scores over 24 months of treatment. The x-axis represents months of treatment (0 to 24), and the y-axis shows mean change from baseline in AUA-SI scores. Two lines compare placebo and dutasteride groups, with dutasteride showing a greater reduction in score over time. Sample sizes for both groups are indicated below the graph.*

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Fig2 (Fig2)

A line graph showing the percent of subjects developing acute urinary retention over a 24-month period in randomized, double-blind, placebo-controlled trials. The x-axis represents months of treatment (0 to 24), and the y-axis shows the percent of patients (0% to 6%). There are two lines: a higher one for the placebo group and a lower one for the Dutasteride group. Cumulative events and numbers at risk are listed below for both groups across the timeline.*

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Fig3 (Fig3)

A line graph showing the percent of subjects having surgery for benign prostatic hyperplasia over a 24-month period from randomized, double-blind, placebo-controlled trials. The graph compares two groups: a placebo group and a dutasteride group. The x-axis represents months of treatment from 0 to 24, and the y-axis shows the percent of patients from 0 to 6. The placebo group line increases more steeply than the dutasteride group line. Cumulative event counts and numbers at risk are provided for both groups at 0, 6, 12, 18, and 24 months.*

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Fig4 (Fig4)

A bar graph titled 'Prostate Volume Percent Change from Baseline' showing mean percent changes over months of treatment in randomized, double-blind, placebo-controlled trials pooled. The x-axis represents months of treatment (0, 1, 3, 6, 12, 24), and the y-axis shows mean percent change from baseline with values decreasing. Black bars represent placebo groups and white bars represent Dutasteride groups, with Dutasteride showing greater percent reductions at each time point.*

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Fig5 (Fig5)

A line graph titled 'Qmax Change from Baseline (Randomized, Double-blind, Placebo-Controlled Trials Pooled)' showing mean change in Qmax (mL/sec) over 24 months of treatment. Two lines represent placebo and Dutasteride groups with corresponding sample sizes noted. The Dutasteride group shows a greater increase in Qmax compared to placebo over time.*

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Fig6 (Fig6)

A line graph depicting the mean change from baseline in International Prostate Symptom Score (IPSS) over a 48-month treatment period. The graph compares three groups: Dutasteride 0.5 mg, Tamsulosin 0.4 mg, and their combination, showing symptom score changes on the y-axis and months of treatment on the x-axis, including sample sizes for each group at different intervals.*

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Fig7 (Fig7)

A line graph showing the Qmax change from baseline (mL/sec) over a 24-month period in a randomized, double-blind, parallel-group trial (CombAT Trial). The x-axis represents months of treatment (0-24), and the y-axis shows mean change from baseline. Three treatment groups are compared: Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg, with sample sizes noted for each time point.*

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Structure (Structure)

Chemical structure diagram of dutasteride, showing its steroid backbone and functional groups including trifluoromethyl-substituted aromatic ring, ketone, and amide functionalities.*

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Tab1 (Tab1)

A data table titled 'Adverse Reactions Reported in ≥1% of Subjects over a 24-Month Period and More Frequently in the Group Receiving Dutasteride than the Placebo Group.' It shows adverse reaction rates for impotence, decreased libido, ejaculation disorders, and breast disorders, comparing percentages for Dutasteride and placebo groups at different time intervals (0-6, 7-12, 13-18, and 19-24 months). Footnotes explain that sexual adverse reactions are linked to dutasteride treatment and breast disorders include tenderness and enlargement.*

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Tab2 (Tab2)

A table presenting adverse reactions reported over a 48-month period in subjects treated with Dutasteride, Tamsulosin, or their combination. The table shows the percentage occurrence of reactions such as ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness at different time intervals from 0 to 48 months.*

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Label (Lbl636291222)

Label for Dutasteride Capsule, Liquid Filled, USP 0.5 mg by Bryant Ranch Prepack. The label includes the NDC 63629-1222-1, states the package contains 90 capsules, and features storage and safety instructions. The label shows barcodes and the BRP Pharmaceuticals logo.*

* 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.