Tadalafil
Product Images NDC 71610-303

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71610-303). 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

Structural Formula (30ee4705 36a5 4a56 852d 9d76c40668db 01)

Chemical structure of the active ingredient Tadalafil, showing its molecular framework with multiple ring systems and functional groups.*

FDA Label Image

Figure 1 (30ee4705 36a5 4a56 852d 9d76c40668db 02)

This figure contains four line graphs showing the difference in blood pressure (Tadalafil minus Placebo) over time in hours. The graphs represent Standing Systolic BP, Standing Diastolic BP, Supine Systolic BP, and Supine Diastolic BP, with y-axes showing the difference in mmHg and x-axes showing time up to 96 hours.*

FDA Label Image

Figure 2 (30ee4705 36a5 4a56 852d 9d76c40668db 03)

This figure presents two line graphs depicting changes in systolic blood pressure (BP) over 24 hours post-dose. The top graph shows standing systolic BP changes comparing Tadalafil 20 mg with doxazosin 8 mg to placebo with doxazosin 8 mg. The bottom graph displays supine systolic BP changes over time for the same treatments.*

FDA Label Image

Figure 3 (30ee4705 36a5 4a56 852d 9d76c40668db 04)

A line graph illustrating the effect on systolic blood pressure (mmHg) over time, up to 12 hours, following administration of 20 mg tadalafil or placebo combined with 8 mg doxazosin at 08:00 or 20:00. The graph compares blood pressure changes for each treatment and time combination with distinct line patterns.*

FDA Label Image

Figure 4 (30ee4705 36a5 4a56 852d 9d76c40668db 05)

A line graph depicting plasma tadalafil concentration (µg/L) over time (hours) comparing three dosing regimens: single 20-mg dose, single 5-mg dose, and once-daily 5-mg dose after 5 consecutive days. The graph shows concentration decay over 120 hours with error bars representing variability.*

FDA Label Image

Figure 5 (30ee4705 36a5 4a56 852d 9d76c40668db 06)

A line graph showing change from baseline in IPSS total score over 12 weeks of treatment comparing Tadalafil 5 mg and placebo. The x-axis represents duration of treatment in weeks (0, 4, 8, 12), and the y-axis indicates change from baseline in IPSS total score, with negative values indicating improvement. The graph shows a greater reduction in score for Tadalafil 5 mg compared to placebo, with statistical significance noted at 12 weeks (p<0.01).*

FDA Label Image

Figure 6 (30ee4705 36a5 4a56 852d 9d76c40668db 07)

A line graph showing the change from baseline in IPSS total score over a 12-week treatment duration comparing Tadalafil 5 mg and placebo. The x-axis represents the weeks of treatment (0, 1, 4, 8, 12), and the y-axis shows the change in IPSS score. Tadalafil shows a greater decrease in score over time compared to placebo, with statistical significance noted at some points (p<0.01).*

FDA Label Image

Figure 7 (30ee4705 36a5 4a56 852d 9d76c40668db 08)

A line graph showing least-squares mean change from baseline over weeks of therapy (0, 4, 12, 26) for two groups: Tadalafil/Finasteride and Placebo/Finasteride. The Tadalafil/Finasteride group shows greater negative change compared to Placebo/Finasteride, with statistical significance indicated at several time points.*

FDA Label Image

Figure 8 (30ee4705 36a5 4a56 852d 9d76c40668db 09)

A line graph showing change from baseline in IPSS Total Score over a 12-week treatment period, comparing Tadalafil 5 mg to placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows change from baseline score. Tadalafil shows a greater reduction in IPSS score than placebo, with statistical significance indicated at 12 weeks (p<0.01).*

FDA Label Image

Torrent Logo (30ee4705 36a5 4a56 852d 9d76c40668db 10)

FDA Label Image

Torrent Logo-pi (30ee4705 36a5 4a56 852d 9d76c40668db 11)

FDA Label Image

Bottle Label 20 mg (71610 0303 04)

Tadalafil USP 20 mg tablets label showing storage instructions, manufacturer Torrent Pharmaceuticals LTD in Indrad, India, and package by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label includes NDC 71610-0303-04, quantity of 4 tablets, and RX Only designation. The label also contains barcodes and lot information.*

FDA Label Image

Aphena Pharma Solutions (TN)

* 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.