Finasteride Tablet, Film Coated
Product Images NDC 76282-412

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Finasteride (NDC 76282-412). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Exelan 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.

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Mm1 (Mm1)

Chemical structure diagram of finasteride, showing its molecular framework with various rings and side groups commonly associated with this medication.*

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

Line graph titled 'Symptom Score in A Long-Term Efficacy and Safety Study' compares mean change from baseline symptom scores over four years between Finasteride (5 mg, film coated tablet) and placebo groups. The vertical axis shows mean change from baseline scores, with Finasteride showing greater symptom score reduction compared to placebo throughout the study period. Sample sizes at each time point are listed for both groups below the horizontal axis.*

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

A line graph labeled Figure 2 showing the percent of patients having surgery for BPH, including TURP, over an observation time of 48 months. It compares Finasteride versus Placebo groups, with cumulative event numbers and patients at risk listed below for each group at intervals. The Finasteride group has a lower percentage of patients undergoing surgery compared to the placebo group over time.*

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Figure 4 Prostate Volume In A Long-term Efficacy And Safety Study (Mm4)

A line graph titled 'Percent of Patients Developing Acute Urinary Retention (Spontaneous and Precipitated)' comparing Finasteride and Placebo groups. The x-axis shows observation time in months (0 to 48), and the y-axis shows percent of patients (0% to 15%). The Placebo group line shows a higher cumulative percentage over time than the Finasteride group. Below the graph are tables detailing cumulative numbers of events and patients at risk yearly for both groups.*

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Figure 5 Cumulative Incidence Of A 4-point Rise In Aua Symptom Score By Treatment Group (Mm5)

Line graph titled 'Prostate Volume in A Long-Term Efficacy and Safety Study' showing mean percent change from baseline in prostate volume over four years. The graph compares two groups: placebo (increasing trend) and finasteride (decreasing trend). Data points are plotted from baseline to year 4, with sample sizes and cumulative events indicated below.*

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5mg-90 (Mm6)

A line graph titled '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. The graph compares placebo, finasteride, doxazosin, and combination treatments over 5.5 years, illustrating incidence rates for each group.*

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Mm7

Label for Finasteride Tablets, USP 5 mg oral film-coated tablets by Exelan Pharmaceuticals Inc. The label includes storage instructions, usage warnings, and dosage information. It states a package count of 90 tablets, is marked Rx Only, and features a barcode and QR code on the left side.*

FDA Label Image

Mm8

Finasteride Tablets USP 5 mg film-coated oral tablets label from Exelan Pharmaceuticals Inc. The package contains 90 tablets. The label includes storage instructions, a warning that women who are or may be pregnant should not use the product, and directs pharmacists to dispense with patient information. Manufacturer details for InvaGen Pharmaceuticals and Exelan Pharmaceuticals are also shown.*

* 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.