Finasteride Tablet, Film Coated
Product Images NDC 65862-149

7 FDA label images from Aurobindo Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Finasteride (NDC 65862-149). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1 Symptom Score In A Long-term Efficacy And Safety Study (Finasteride Fig1)

Figure 1 Symptom Score In A Long-term Efficacy And Safety Study (Finasteride Fig1)
A line graph titled 'Symptom Score in a Long-Term Efficacy and Safety Study' shows mean change from baseline with standard error bars over four years. It compares Finasteride and placebo groups, with Finasteride showing a greater reduction in symptom scores over time. Participant numbers for each year are noted for both groups.*
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Figure 2 Percent Of Patients Having Surgery For Bph, Including Turp (Finasteride Fig2)

Figure 2 Percent Of Patients Having Surgery For Bph, Including Turp (Finasteride Fig2)
A line graph titled 'Percent of Patients Having Surgery for BPH, Including TURP' comparing Finasteride and Placebo groups over 48 months. The y-axis shows the percent of patients (0% to 15%), and the x-axis shows observation time in months (0 to 48). Two lines represent Finasteride (solid) and Placebo (dotted), with the Placebo group consistently showing a higher cumulative percent. Below, tables detail cumulative event numbers and patients at risk per year for both groups.*
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Figure 4 Prostate Volume In A Long-term Efficacy And Safety Study (Finasteride Fig3)

Figure 4 Prostate Volume In A Long-term Efficacy And Safety Study (Finasteride Fig3)
A line graph depicting the percent of patients developing acute urinary retention over 48 months, comparing finasteride and placebo groups. The x-axis represents observation time in months, and the y-axis shows the percent of patients. The placebo group shows a higher cumulative percentage than the finasteride group, whose line remains lower throughout. Below the graph are tables with cumulative event counts and numbers at risk per year for both groups.*
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Figure 5 Cumulative Incidence Of A 4-point Rise In Aua Symptom Score By Treatment Group (Finasteride Fig4)

Figure 5 Cumulative Incidence Of A 4-point Rise In Aua Symptom Score By Treatment Group (Finasteride Fig4)
A line graph titled 'Prostate Volume in a Long-Term Efficacy and Safety Study' showing mean percent change from baseline ± 1 SE over four years. The graph compares placebo and finasteride groups, with placebo showing an increase and finasteride showing a decrease in prostate volume. Sample sizes for each group at baseline and yearly intervals are provided below the graph.*
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Finasteride-fig5 (Finasteride Fig5)

Finasteride-fig5 (Finasteride Fig5)
A line graph depicting the cumulative incidence of a 4-point rise in AUA symptom score over 5.5 years in different treatment groups: Placebo, Finasteride, Doxazosin, and a Combination group. The y-axis shows percent with event, and the x-axis shows years from randomization, illustrating lower incidence rates for active treatments compared to placebo.*
FDA Label Image

Finasteride Fig6

Finasteride Fig6
Label for Finasteride Tablets, USP 5 mg film-coated tablets. The label indicates prescription use only, provides a warning about use in women and children, and includes storage instructions. It shows the labeler as Aurobindo Pharma Limited with distribution by Aurobindo Pharma USA, Inc. The package contains 100 tablets. Barcodes and lot coding area are also visible.*
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Chemical Structure (Finasteride Str)

Chemical Structure (Finasteride Str)
Chemical structure of Finasteride, showing its characteristic steroid framework with specific functional groups including a lactam ring and multiple methyl substitutions. The diagram depicts the molecule's detailed atomic arrangement as related to the active ingredient in the 5 mg film-coated tablet by Aurobindo Pharma Limited.*

* 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.