Dutasteride
Product Images NDC 53345-037

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 53345-037). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Humanwell Puracap Pharmaceutical (wuhan), Ltd., 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

Bulk Label (Bulk Duta)

Label from Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. for Dutasteride Capsules 0.5 mg. The label shows each softgel contains 0.5 mg of Dutasteride. It indicates a bulk quantity of 12,000 capsules with product code 40-10001. Storage instructions specify protection from heat, humidity, and light, with recommended temperatures of 25°C (77°F) and excursions between 15-30°C (59-86°F). The product is made in China.*

FDA Label Image

Figure-1 (Figure 1)

A line graph depicting the mean change from baseline in AUA-SI over 24 months of treatment, comparing Dutasteride and Placebo groups. The x-axis represents months of treatment (0 to 24), and the y-axis shows mean change from baseline. Dutasteride shows a larger decrease over time than Placebo, with sample sizes around 2,122 per group at each time point.*

FDA Label Image

Figure-2 (Figure 2)

A line graph comparing the cumulative percent of patients over 24 months of treatment between Dutasteride and placebo groups. The x-axis shows months of treatment from 0 to 24, and the y-axis shows the percent of patients from 0 to 6. Two lines represent the placebo group and dutasteride group with cumulative event and at-risk counts provided at intervals (0, 6, 12, 18, 24 months). The placebo group's event rate rises faster than the dutasteride group's over time.*

FDA Label Image

Figure-3 (Figure 3)

A line graph comparing the percent of patients over 24 months of treatment between a placebo group and a dutasteride group. The x-axis represents months of treatment from 0 to 24, and the y-axis shows the percent of patients from 0 to 6%. Two lines indicate cumulative events for each group, with the placebo group's line generally higher than the dutasteride group's. Below the graph, cumulative event counts and number of patients at risk are presented for multiple time points for both groups.*

FDA Label Image

Figure-4 (Figure 4)

A bar chart comparing the mean percent change from baseline over time for Dutasteride versus placebo treatment groups. The x-axis represents months of treatment at intervals 0, 1, 3, 6, 12, and 24, while the y-axis shows mean percent change from baseline. Dutasteride consistently shows larger decreases compared to placebo across all time points, with sample sizes noted below each time interval for both groups.*

FDA Label Image

Figure-5 (Figure 5)

A line graph comparing the mean change from baseline (mL/sec) over 24 months of treatment between Dutasteride and Placebo groups. The x-axis represents months of treatment from 0 to 24, and the y-axis shows mean change values from 0 to 2. Dutasteride shows a higher and increasing mean change over time compared to the relatively stable Placebo group.*

FDA Label Image

Figure-6 (Figure 6)

A line graph depicting the mean change from baseline in IPSS over 48 months of treatment. The graph compares three groups: Dutasteride + tamsulosin, Dutasteride 0.5 mg, and Tamsulosin 0.4 mg. Sample sizes for each group at various times are noted, showing treatment effects across time.*

FDA Label Image

Figure-7 (Figure 7)

A line graph showing the mean change from baseline in mL/sec over 24 months of treatment. It compares three groups: Dutasteride with tamsulosin, Dutasteride 0.5 mg alone, and Tamsulosin 0.4 mg alone, with sample sizes noted for each time point from 6 to 24 months.*

FDA Label Image

Structural-formula (Image 01)

Chemical structure of the active ingredient Dutasteride, showing its steroid-like core and trifluoromethyl-substituted aromatic ring.*

* 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.