Dutasteride Capsule, Liquid Filled
Product Images NDC 72865-140

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 72865-140). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare 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 XLCare Pharmaceuticals, Inc. The label states each capsule contains 0.5 mg dutasteride and comes in a 30-capsule package. It includes a warning against use by women or children, storage instructions, and manufacturer details for XLCare Pharmaceuticals and Ascent Pharmaceuticals.*

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0.5 mg 90s

Label for Dutasteride 0.5 mg capsules, liquid filled, oral dosage form, by XLCare Pharmaceuticals, Inc. The label shows the NDC 72865-140-90 and indicates a package containing 90 capsules. It includes warnings about use by women or children, dosing instructions, storage temperatures, and manufacturer information. The label emphasizes "Rx Only" and notes to check the safety seal under the cap.*

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Fig1

A line graph titled 'AUA-SI Score Change from Baseline' showing mean change from baseline in AUA-SI scores over 24 months of treatment. The graph compares placebo and Dutasteride groups in randomized, double-blind, placebo-controlled pooled trials, with separate lines and markers for each treatment. The x-axis shows months of treatment from 0 to 24, and the y-axis shows mean changes from baseline in AUA-SI scores, ranging roughly from 0 to -4. Sample sizes are indicated for each time point.*

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Fig2

A line graph titled 'Percent of Subjects Developing Acute Urinary Retention over a 24-Month Period' from 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%). Two lines compare the placebo group and the dutasteride group, showing higher rates in the placebo group. Below the graph, tables list cumulative events and numbers at risk for each group at 0, 6, 12, 18, and 24 months.*

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Fig3

A line graph depicting the percent of subjects undergoing surgery for benign prostatic hyperplasia over a 24-month period in randomized, double-blind, placebo-controlled trials. The graph compares the placebo group and the dutasteride group, showing cumulative events and number at risk at intervals from 0 to 24 months of treatment.*

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Fig4

A bar graph showing prostate volume percent change from baseline over treatment months for Dutasteride and placebo groups in pooled randomized, double-blind, placebo-controlled trials. The x-axis shows months of treatment (0, 1, 3, 6, 12, 24) and the y-axis shows mean percent change from baseline. Dutasteride bars indicate a greater reduction in prostate volume compared to placebo at each time point.*

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Fig5

A line graph titled 'Qmax Change from Baseline (Randomized, Double-blind, Placebo-Controlled Trials Pooled)' showing mean changes 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 ml/sec, ranging from 0 to 2. Two lines compare placebo (black squares) and Dutasteride (white circles) with Dutasteride showing a higher increase over time.*

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Fig6

A line graph showing the International Prostate Symptom Score (IPSS) change from baseline over a 48-month period for three treatment groups: Dutasteride 0.5 mg, Tamsulosin 0.4 mg, and Dutasteride combined with Tamsulosin. The x-axis represents months of treatment up to 48, and the y-axis represents mean change from baseline in IPSS. The graph depicts the trend of symptom score changes in a randomized, double-blind, parallel-group trial (CombAT Trial) with sample sizes of approximately 1,575 per group.*

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Fig7

A line graph depicting Qmax change from baseline over a 24-month period in a randomized, double-blind, parallel-group trial (CombAT Trial). The y-axis shows mean change from baseline in mL/sec, and the x-axis shows months of treatment at 0, 6, 12, 18, and 24 months. Three treatment groups are compared: Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg, with sample sizes provided at each time point.*

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Structure

Chemical structure of Dutasteride, a steroidal compound characterized by multiple fused rings, amide groups, and trifluoromethyl substituents on a phenyl ring.*

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Tab1

Table showing adverse reactions reported in 1% or more of subjects over 24 months, comparing Dutasteride 0.5 mg liquid-filled capsules to placebo. It lists onset timings across four periods (0-6, 7-12, 13-18, 19-24 months) for impotence, decreased libido, ejaculation disorders, and breast disorders, with footnotes explaining sexual adverse reactions and breast disorder definitions.*

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Tab2

A data table titled 'Table 2. 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 lists adverse reactions such as ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness, showing the percentage incidence across different time intervals (Months 0-6, Months 7-12, Years 2, 3, and 4) for three groups: Combination therapy, Dutasteride monotherapy, and Tamsulosin monotherapy. Footnotes clarify definitions of combination therapy and types of sexual adverse reactions included.*

* 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.