Dutasteride
Product Images NDC 0115-1438

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 0115-1438). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Impax Generics, 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

Dutasterided Structure (Dutasteride Capsules 1)

Chemical structure diagram of the active ingredient dutasteride, showing its steroid-like core with trifluoromethyl substituents on the aromatic ring and amide functional groups.*

FDA Label Image

0.5mg-90ct (Dutasteride Capsules 10)

Label for Dutasteride Capsules 0.5 mg by Impax Generics, showing a package containing 90 capsules. The label includes a warning against use by women or children, storage instructions, and dispensing guidelines. It lists the distributor as Impax Generics in Hayward, CA, and notes the product is made in India. The NDC on the label is 0115-1438-10.*

FDA Label Image

Figure 1 Aua-si Scorea Change From Baseline (randomized, Double-blind, Placebo-controlled Studies Pooled) (Dutasteride Capsules 2)

A line graph depicting the mean change from baseline in AUA-SI over 24 months of treatment comparing Dutasteride and placebo. The x-axis represents months of treatment, and the y-axis shows mean change from baseline. Dutasteride shows a greater decrease in AUA-SI over time compared to placebo, with data points and sample sizes indicated for each group.*

FDA Label Image

Figure 2 Percent Of Subjects Developing Acute Urinary Retention Over A 24-month Period (randomized, Double-blind, Placebo-controlled Studies Pooled) (Dutasteride Capsules 3)

A line graph depicting the cumulative incidence of events over 24 months of treatment for Dutasteride versus a placebo group. The y-axis shows percent of patients, and the x-axis represents months of treatment. The chart includes event counts and numbers at risk for each group at multiple time points.*

FDA Label Image

Figure 3 Percent Of Subjects Having Surgery For Benign Prostatic Hyperplasia Over A 24-month Period (randomized, Double-blind, Placebo-controlled Studies Pooled (Dutasteride Capsules 4)

A line chart comparing placebo and dutasteride groups showing the percent of patients over 24 months of treatment. The graph includes cumulative number of events and patients at risk for each group at various time points.*

FDA Label Image

Figure 4 Prostate Volume Percent Change From Baseline (randomized, Double-blind, Placebo-controlled Studies Pooled) (Dutasteride Capsules 5)

A bar chart showing the mean percent change from baseline over months of treatment (0, 1, 3, 6, 12, 24) comparing placebo and Dutasteride groups. The chart depicts a greater decrease with Dutasteride compared to placebo at each time point. Sample sizes for each group at each time point are indicated below the bars.*

FDA Label Image

Figure 5 Qmax Change From Baseline (randomized, Double-blind, Placebo-controlled Studies Pooled) (Dutasteride Capsules 6)

A line graph depicting the mean change from baseline (mL/sec) over 24 months of treatment, comparing Dutasteride and Placebo. The x-axis represents months of treatment (0 to 24), and the y-axis indicates mean change from baseline. Dutasteride shows a greater increase over time compared to Placebo, with sample sizes listed for each time point.*

FDA Label Image

Figure 6 International Prostate Symptom Score Change From Baseline Over A 48-month Period (randomized, Double-blind, Parallel Group Study [combat Study]) (Dutasteride Capsules 7)

A line graph showing the mean change from baseline in IPSS (International Prostate Symptom Score) over 48 months of treatment for three groups: Dutasteride plus tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg, with sample sizes listed for each treatment group at different time points.*

FDA Label Image

Figure 7 Qmax Change From Baseline Over A 24-month Period (randomized, Double-blind, Parallel Group Study [combat Study]) (Dutasteride Capsules 8)

A line graph depicting mean change from baseline (mL/sec) over 24 months of treatment for Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Dutasteride 0.4 mg. The x-axis represents months of treatment (0 to 24), and the y-axis shows mean change from baseline in mL/sec (0 to 3.0). Three lines with different markers illustrate the data trends for each treatment group over time.*

FDA Label Image

0.5mg-30ct (Dutasteride Capsules 9)

Label for Dutasteride Capsules 0.5 mg by Impax Generics, containing 30 capsules. The label includes usage warnings, storage instructions, and safety information. It features the NDC number 0115-1438-08 and identifies the product as distributed by Impax Generics in Hayward, CA.*

* 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.