Dutasteride Capsule, Liquid Filled
Product Images NDC 72162-1296

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 72162-1296). 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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Fig 1 (Fig1)

A line graph titled "AUA-SI Score Change from Baseline (Randomized, Double-blind, Placebo-Controlled Trials Pooled)" displaying mean change from baseline in AUA-SI score over 24 months of treatment. The x-axis represents months of treatment (0 to 24), and the y-axis shows mean change, ranging from 0 to -4. Two lines represent placebo and dutasteride groups, with dutasteride showing a greater decrease in score over time. Sample sizes are noted below the x-axis for each time point.*

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Fig 2 (Fig2)

A line graph titled 'Percent of Subjects Developing Acute Urinary Retention over a 24-Month Period' showing data from randomized, double-blind, placebo-controlled trials pooled. The x-axis represents months of treatment from 0 to 24, and the y-axis shows percent of patients from 0 to 6 percent. Two groups are plotted: Placebo (dashed line) and Dutasteride (solid line). The placebo group shows a higher cumulative percentage of patients developing acute urinary retention over time compared to the Dutasteride group. Below the graph, cumulative number of events and number of patients at risk are tabulated for both groups at 0, 6, 12, 18, and 24 months.*

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Fig 3 (Fig3)

A line graph comparing the percent of patients having surgery for benign prostatic hyperplasia over a 24-month period in randomized, double-blind, placebo-controlled trials. Two groups are shown: Placebo Group and Dutasteride Group, with cumulative event counts and numbers at risk listed at months 0, 6, 12, 18, and 24.*

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Fig 4 (Fig4)

A bar chart depicting prostate volume percent change from baseline over time in months for Dutasteride versus placebo in randomized, double-blind, placebo-controlled trials. Bars indicate mean percent change at 1, 3, 6, 12, and 24 months of treatment, with Dutasteride shown by white bars and placebo by black bars.*

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Fig 5 (Fig5)

Line graph showing the change in maximum urinary flow rate (Qmax) from baseline over 24 months in randomized, double-blind, placebo-controlled trials. The x-axis represents months of treatment (0 to 24), and the y-axis shows mean change from baseline in mL/sec. Two lines illustrate results for placebo and Dutasteride groups with sample sizes near 2,100 per group at each time point.*

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Fig 6 (Fig6)

A line graph titled 'International Prostate Symptom Score Change from Baseline over a 48-Month Period' from a randomized, double-blind, parallel-group trial (CombAT Trial). It shows mean change from baseline in IPSS versus months of treatment (0 to 48) for three groups: Dutasteride + Tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg. The graph tracks IPSS score improvements with data points and sample sizes for each group at various time intervals.*

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Fig 7 (Fig7)

A line graph titled 'Qmax Change from Baseline over a 24-Month Period (Randomized, Double-blind, Parallel-Group Trial [CombAT Trial])' showing mean change from baseline (mL/sec) on the y-axis and months of treatment up to 24 months on the x-axis. It compares three groups: Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg, with sample sizes noted at various time points for each group.*

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Structure (Structure)

Chemical structure of Dutasteride, showing its detailed molecular framework including fused rings and trifluoromethyl groups.*

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Tab 1 (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 summarizes adverse reactions (impotence, decreased libido, ejaculation disorders, breast disorders) by time of onset across four 6-month intervals, comparing percentages between Dutasteride and placebo groups in a randomized, double-blind, placebo-controlled trial pooling.*

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Tab 2 (Tab2)

A data table titled 'Adverse Reactions Reported over a 48-Month Period in ≥1% of Subjects and More Frequently in the Coadministration Therapy Group than the Groups Receiving Monotherapy with Dutasteride or Tamsulosin (CombAT) by Time of Onset.' It presents the incidence percentages of various adverse reactions such as ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness across different time intervals (months 0-6, year 1 months 7-12, years 2, 3, and 4) for three groups: Combination therapy, Dutasteride monotherapy, and Tamsulosin monotherapy. Footnotes clarify definitions and details about the adverse reactions and combination therapy.*

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Label (Lbl721621296)

Dutasteride Capsules 0.5 mg label, showing the 72162-1296 NDC code. The label states the product contains 30 capsules, is Rx only, and includes directions for storage and usage. It is relabeled by Bryant Ranch Prepack, Inc. and manufactured by Ascent Pharmaceuticals, Inc. The label includes a barcode and a QR code on the left side.*

* 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.