Tadalafil Tablet
Product Images NDC 71610-903

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71610-903). 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

Label (71610 0903 04)

Tadalafil USP 20 mg oral tablets label showing a 4-tablet count. The label includes storage instructions, manufacturer information (Prinston Laboratories, Charlotte, NC), and repackager details (Aphena Pharma, Cookeville, TN). The product is prescription-only, with NDC 71610-903-04 visible.*

FDA Label Image

Aphena (Aphena)

FDA Label Image

F35596a7-figure-01 (F35596a7 Figure 01)

Chemical structure of tadalafil shown as a 2D molecular diagram, depicting its fused rings and functional groups consistent with the active ingredient tadalafil.*

FDA Label Image

F35596a7-figure-02 (F35596a7 Figure 02)

Four line graphs showing blood pressure changes over time comparing tadalafil 20 mg tablets to placebo. The graphs depict differences in standing systolic BP, standing diastolic BP, supine systolic BP, and supine diastolic BP measured in mmHg over approximately 96 hours.*

FDA Label Image

F35596a7-figure-03 (F35596a7 Figure 03)

A dual-line graph showing the effects over 24 hours post-dose on standing and supine systolic blood pressure (BP) in mmHg. The top graph compares tadalafil 20 mg with doxazosin 8 mg against placebo with doxazosin 8 mg for standing systolic BP. The bottom graph shows the same comparison for supine systolic BP. Time post-dose in hours is plotted on the x-axis for both graphs.*

FDA Label Image

F35596a7-figure-04 (F35596a7 Figure 04)

A line graph showing changes in systolic blood pressure (mmHg) over 12 hours following administration of 20 mg tadalafil or placebo combined with 8 mg doxazosin. The x-axis represents time after administration, and the y-axis depicts systolic blood pressure changes in mmHg. Data series include morning and evening dosing for both tadalafil and placebo groups.*

FDA Label Image

F35596a7-figure-05 (F35596a7 Figure 05)

A line graph showing plasma tadalafil concentration (µg/L) over time (hours) for three dosing regimens: single 20-mg dose, single 5-mg dose, and once-daily 5-mg dose following 5 consecutive days of administration. The y-axis represents plasma tadalafil concentration from 0 to 500 µg/L, and the x-axis represents time from 0 to 120 hours, with data points and error bars indicated for each regimen.*

FDA Label Image

F35596a7-figure-06 (F35596a7 Figure 06)

A line graph comparing the change from baseline in IPSS total score over 12 weeks of treatment between tadalafil 5 mg tablets and placebo. The x-axis shows treatment duration in weeks, and the y-axis shows the change in score, with tadalafil showing a greater decrease in symptoms compared to placebo. Statistically significant difference is indicated at week 12 (p < 0.01).*

FDA Label Image

F35596a7-figure-07 (F35596a7 Figure 07)

Line graph comparing change from baseline in IPSS Total Score over 12 weeks of treatment between tadalafil 5 mg tablets and placebo. The graph shows a greater reduction in score with tadalafil compared to placebo, with statistical significance indicated at week 4 and week 12 (p < 0.01). The x-axis represents duration of treatment in weeks; the y-axis shows change from baseline in IPSS Total Score.*

FDA Label Image

F35596a7-figure-08 (F35596a7 Figure 08)

A line graph showing least-squares mean change from baseline over 26 weeks of therapy. It compares Tadalafil/Finasteride and Placebo/Finasteride groups, with data points at 0, 4, 12, and 26 weeks. The graph includes statistical significance markers (p<0.001 and p<0.05) for changes at weeks 4, 12, and 26.*

FDA Label Image

F35596a7-figure-09 (F35596a7 Figure 09)

A line graph showing change from baseline in IPSS total scores over 12 weeks comparing tadalafil tablets 5 mg and placebo. The x-axis represents duration of treatment in weeks (0, 2, 4, 8, 12), and the y-axis shows the change from baseline with negative values indicating score reduction. The tadalafil group demonstrates a greater decrease over time compared to placebo, with a statistically significant difference at 12 weeks (p < 0.01).*

* 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.