Dutasteride
Product Images NDC 0115-1438

View Photos of Packaging, Regulatory Labels, and Product Appearance

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.

Product Images & Figures Index

FDA Label Image

Dutasterided Structure (Dutasteride Capsules 1)

Dutasterided Structure (Dutasteride Capsules 1)
FDA Label Image

0.5mg-90ct (Dutasteride Capsules 10)

0.5mg-90ct (Dutasteride Capsules 10)
FDA Label Image

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

Figure 1 Aua-si Scorea Change From Baseline (randomized, Double-blind, Placebo-controlled Studies Pooled) (Dutasteride Capsules 2)
The text describes a chart or graph that represents the mean change from baseline in AUA-SI (American Urological Association Symptom Index) over a period of 18 months of treatment. The horizontal axis indicates the months of treatment, while the vertical axis represents the mean change value. The chart includes data for both a placebo group and a group treated with dutasteride.*
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)

Figure 2 Percent Of Subjects Developing Acute Urinary Retention Over A 24-month Period (randomized, Double-blind, Placebo-controlled Studies Pooled) (Dutasteride Capsules 3)
This appears to be a chart displaying data related to the percentage of patients in the Placebo group and Dutasterie group over the course of several months of treatment. The chart shows the number of events at each stage and the cumulative percentage of patients. However, without additional context or information it is difficult to interpret the data or provide any additional insights.*
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)

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)
FDA Label Image

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

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

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

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

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)
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)

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

0.5mg-30ct (Dutasteride Capsules 9)

0.5mg-30ct (Dutasteride Capsules 9)
This appears to be a medication label for Dutasteride capsules, with dosage information and warnings about who should use the medication. It also includes specific information about the product, including its NDC number, lot number and an expiration date. The label cautions that these capsules should not be used by women or children and includes a warning about potential contact with leaking capsules, advising users to wash it immediately with soap and water.*

* 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.