Dutasteride Capsule, Liquid Filled
Product Images NDC 31722-131

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 31722-131). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber 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

0.5 mg 30s

Label for Dutasteride Capsules 0.5 mg by Camber Pharmaceuticals, Inc., NDC 31722-131-30. The label states it contains 30 liquid-filled oral capsules. Additional manufacturer information includes Ascent Pharmaceuticals, Inc. Directions and warnings are included regarding dosage, storage, and safety.*

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0.5 mg 90s

Dutasteride 0.5 mg capsules liquid filled in an oral dosage form, manufactured by Camber Pharmaceuticals, Inc. The label indicates a package containing 90 capsules with storage instructions and warnings. The product is an Rx prescription drug with NDC 31722-131-90, featuring a barcode and manufacturer details including Ascent Pharmaceuticals, Inc.*

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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 in AUA-SI score on the y-axis and months of treatment on the x-axis from 0 to 24 months. It compares Dutasteride and placebo groups, with Dutasteride showing a greater decrease in score over time. Sample sizes for each group at various time points are provided 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 from randomized, double-blind, placebo-controlled trials pooled data. The x-axis represents months of treatment (0 to 24), and the y-axis shows the percent of patients (0 to 6%). Two lines compare the placebo group and the dutasteride group, with cumulative event counts and numbers at risk listed below the graph for various time points.*

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Fig3 (Fig3)

A line graph showing the percent of subjects undergoing surgery for benign prostatic hyperplasia over 24 months, comparing placebo and dutasteride groups in randomized, double-blind, placebo-controlled trials. The x-axis represents months of treatment (0 to 24), and the y-axis represents percent of patients (0 to 6). The placebo group shows a higher cumulative percent over time than the dutasteride group, with event and risk numbers detailed below the graph.*

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Fig4 (Fig4)

A bar chart showing prostate volume percent change from baseline over months of treatment in randomized, double-blind, placebo-controlled trials. It compares placebo and Dutasteride groups at 1, 3, 6, 12, and 24 months, with Dutasteride showing greater reductions in prostate volume percentage compared to placebo over time.*

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Fig5 (Fig5)

A line graph showing the mean change from baseline in Qmax (mL/sec) over 24 months of treatment, comparing Dutasteride and placebo in randomized, double-blind, placebo-controlled trials. The graph includes data points at multiple time intervals up to 24 months, with Dutasteride showing a higher increase in Qmax compared to placebo.*

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Fig6 (Fig6)

Line graph showing the International Prostate Symptom Score (IPSS) change from baseline over a 48-month period in a randomized, double-blind, parallel-group trial (CombAT Trial). The graph compares mean changes from baseline for three groups: Dutasteride plus tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg, plotted against months of treatment.*

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Fig7 (Fig7)

Line chart titled 'Qmax Change from Baseline over a 24-Month Period' from a randomized, double-blind, parallel-group trial (CombAT Trial). The graph shows mean change from baseline in Qmax (mL/sec) on the vertical axis over months of treatment (0 to 24) on the horizontal axis for three groups: Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg. Sample sizes (n) for each group at 0, 6, 12, 18, and 24 months are also shown.*

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Structure (Structure)

Chemical structure of Dutasteride, showing its steroid backbone with multiple rings, including functional groups such as amide, ketone, and trifluoromethyl-substituted aromatic ring. The structure is consistent with the active ingredient Dutasteride in the product.*

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Tab1 (Tab1)

Table showing adverse reactions reported in 1% or more of subjects over 24 months in randomized, double-blind, placebo-controlled trials comparing Dutasteride and placebo. It details the frequency percentages of impotence, decreased libido, ejaculation disorders, and breast disorders by time of onset intervals (0-6, 7-12, 13-18, 19-24 months). Footnotes explain the association of sexual adverse reactions with Dutasteride and its unknown role in persistence, as well as the inclusion of breast tenderness and enlargement under breast disorders.*

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Tab2 (Tab2)

This table shows adverse reactions reported over a 48-month period occurring in at least 1% of subjects, comparing combination therapy (dutasteride 0.5 mg plus tamsulosin 0.4 mg) with monotherapy groups (dutasteride or tamsulosin alone). It provides the time of onset for ejaculatory disorders, impotence, decreased libido, breast disorders, and dizziness, detailing percentages for each reaction across different time intervals (0-6 months, 7-12 months, and years 2 to 4) for the three treatment groups.*

* 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.