Finasteride Tablet, Film Coated
Product Images NDC 71610-515

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Finasteride (NDC 71610-515). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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

Bottle Label 5 mg (71610 0515 60)

Finasteride 5 mg film-coated tablets packaging label showing a quantity of 90 tablets. Manufactured by Invagen Pharmaceuticals Inc. in Hauppauge, NY, and labeled by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label includes storage instructions to keep the product between 20-25 degrees Celsius, in a tight light-resistant container, and out of reach of children. The product is for prescription use only.*

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Aphena Pharma Solutions (TN)

FDA Label Image

Mm1 (Mm1)

Chemical structure of finasteride, shown as a molecular diagram depicting atoms and bonds characteristic of this active pharmaceutical ingredient.*

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Figure 1 Symptom Score In A Long-term Efficacy And Safety Study (Mm2)

A line graph titled 'Symptom Score in A Long-Term Efficacy and Safety Study' showing mean change from baseline ± 1 SE over four years. It compares symptom scores between Finasteride and placebo groups. The y-axis ranges from 0 to -6, and the x-axis covers Baseline through Year 4. Finasteride shows a more pronounced downward trend in symptom score change compared to placebo.*

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Figure 2 Percent Of Patients Having Surgery For Bph, Including Turp (Mm3)

A line graph showing the percent of patients having surgery for BPH, including TURP, over 48 months of observation time. It compares two groups: Finasteride and Placebo. The Placebo group shows a higher percent of patients undergoing surgery over time compared to the Finasteride group. Below the graph, cumulative events and number at risk per year are listed for both groups.*

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Figure 3 Percent Of Patients Developing Acute Urinary Retention (spontaneous And Precipitated) (Mm4)

A line graph titled 'Percent of Patients Developing Acute Urinary Retention (Spontaneous and Precipitated)' comparing Finasteride and placebo over 48 months. The y-axis shows percent of patients (0-15%), and the x-axis shows observation time in months (0-48). Data tables below show cumulative events and patients at risk per year for placebo and Finasteride groups.*

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Figure 4 Prostate Volume In A Long-term Efficacy And Safety Study (Mm5)

A line graph titled 'Prostate Volume in A Long-Term Efficacy and Safety Study' comparing mean percent change from baseline over four years between placebo and Finasteride groups. The placebo group shows an increasing trend, while the Finasteride group shows a decreasing trend. Sample sizes and cumulative events are listed below the graph.*

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Figure 5 Cumulative Incidence Of A 4-point Rise In Aua Symptom Score By Treatment Group (Mm6)

A line graph titled 'Figure 5 Cumulative Incidence of a 4-Point Rise in AUA Symptom Score by Treatment Group' showing percent with event on the Y-axis and years from randomization on the X-axis. It compares treatment groups: Placebo, Finasteride, Doxazosin, and Combination over a 5.5 year period.*

* 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.