Dutasteride
Product Images NDC 68071-2610

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Dutasteride (NDC 68071-2610). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare 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

Pdp (68071 2610 3)

Label for Dutasteride 0.5 mg capsules from NuCare Pharmaceuticals, Inc. The label indicates a package of 30 capsules with NDC 68071-2610-3. It includes storage instructions to keep at controlled temperature 68-77°F and a warning to keep out of reach of children. The label also references the manufacturer Ascent Pharmaceuticals, Inc, Central Islip, NY, and includes placeholders for lot number, expiration date, and serial numbers.*

FDA Label Image

Fig 1 (Fig1)

A line graph titled 'AUA-SI Score Change from Baseline (Randomized, Double-blind, Placebo-Controlled Trials Pooled)' showing mean change 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 from baseline in AUA-SI. Two lines represent placebo and dutasteride groups, with dutasteride showing a greater decrease in score over time. Sample sizes are noted for each time point, with AUA-SI score ranges from 0 to 35.*

FDA Label Image

Fig 2 (Fig2)

A line graph depicting the percent of subjects developing acute urinary retention over a 24-month period in randomized, double-blind, placebo-controlled trials pooled for Dutasteride versus placebo. The x-axis shows months of treatment from 0 to 24, and the y-axis shows percent of patients from 0 to 6. Two lines represent the placebo group and the Dutasteride group, with the placebo group showing a higher cumulative percentage of events over time. A table below the graph lists the cumulative number of events and number of patients at risk for both groups at specified time points.*

FDA Label Image

Fig 3 (Fig3)

A line graph titled 'Percent of Subjects Having Surgery for Benign Prostatic Hyperplasia over a 24-Month Period' comparing placebo and dutasteride groups in randomized, double-blind, placebo-controlled trials. The x-axis represents months of treatment (0-24), and the y-axis shows the percent of patients undergoing surgery (0-6%). Two lines display cumulative events over time: a dashed line for the placebo group and a solid line for the dutasteride group, with event and risk numbers noted below the graph at 0, 6, 12, 18, and 24 months.*

FDA Label Image

Fig 4 (Fig4)

A bar graph showing mean percent change in prostate volume from baseline over 0, 1, 3, 6, 12, and 24 months of treatment in pooled randomized, double-blind, placebo-controlled trials. The graph compares placebo (black bars) with Dutasteride (white bars), illustrating that Dutasteride results in a greater reduction in prostate volume over time.*

FDA Label Image

Fig 5 (Fig5)

A line chart displaying the mean change from baseline in Qmax (mL/sec) over 24 months of treatment in randomized, double-blind, placebo-controlled pooled trials. Two groups, placebo and dutasteride, are compared, with the dutasteride group showing a greater increase in Qmax over time. Participant counts at different time points are indicated for each group below the x-axis.*

FDA Label Image

Fig 6 (Fig6)

A line graph showing International Prostate Symptom Score (IPSS) change from baseline over 48 months in a randomized, double-blind, parallel-group trial comparing Dutasteride with Tamsulosin, Dutasteride 0.5 mg alone, and Tamsulosin 0.4 mg alone. The y-axis indicates mean change from baseline in IPSS and the x-axis shows months of treatment from 0 to 48.*

FDA Label Image

Fig 7 (Fig7)

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

FDA Label Image

Structure (Structure)

Chemical structure diagram of dutasteride depicting its steroidal backbone with associated functional groups including trifluoromethyl-substituted phenyl moieties.*

FDA Label Image

Tab 1 (Tab1)

A data table presenting adverse reactions reported in 1% or more of subjects over a 24-month period in randomized, double-blind, placebo-controlled trials for Dutasteride versus placebo. The table details the incidence rates for impotence, decreased libido, ejaculation disorders, and breast disorders in defined time intervals from 0 to 24 months, comparing Dutasteride and placebo groups.*

FDA Label Image

Tab 2 (Tab2)

A data table titled 'Table 2' showing adverse reactions reported over a 48-month period in subjects receiving either combination therapy with Dutasteride and Tamsulosin or monotherapy with either Dutasteride or Tamsulosin. The table details percentages of subjects experiencing specific adverse reactions such as ejaculation disorders, impotence, decreased libido, breast disorders, and dizziness, broken down by time of onset from 0-6 months up to year 4.*

* 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.