Tadalafil Tablet, Film Coated
Product Images NDC 71610-603

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71610-603). 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 0603 08)

Tadalafil USP 5 mg tablet label displaying the NDC number 71610-0603-08. The label indicates a package containing 8 film-coated tablets for oral use. Storage instructions specify 20-25 degrees Celsius, and dispensing guidance recommends a tight light-resistant container. The label identifies the manufacturer as Amneal Pharmaceuticals LLC, Brooklyn, NY, and the repackager as Aphena Pharma Solutions, Cookeville, TN. It also notes keeping the medication out of children’s reach and provides lot and expiration details.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

10 (Tadalafil Tablets Usp 1)

Chemical structure diagram of the active ingredient Tadalafil, illustrating its molecular connectivity and ring systems typical of its chemical composition.*

FDA Label Image

10 (Tadalafil Tablets Usp 2)

A figure containing four line graphs showing blood pressure changes over time in hours. The graphs compare standing systolic blood pressure, standing diastolic blood pressure, supine systolic blood pressure, and supine diastolic blood pressure between tadalafil and placebo groups, with the y-axis indicating the difference in mmHg and the x-axis representing time in hours up to 96 hours.*

FDA Label Image

10 (Tadalafil Tablets Usp 3)

Two line graphs showing changes in systolic blood pressure over 24 hours post-dose for Tadalafil 20 mg with doxazosin 8 mg compared to placebo with doxazosin 8 mg. The top graph is for standing systolic blood pressure, the bottom for supine systolic blood pressure. Both graphs plot blood pressure changes in mmHg against time in hours.*

FDA Label Image

10 (Tadalafil Tablets Usp 4)

A line graph depicting the effect on systolic blood pressure (mmHg) over 12 hours after administration of tadalafil or placebo combined with doxazosin. Four lines represent different treatment groups varying in timing and substance, showing blood pressure changes over time post-administration.*

FDA Label Image

10 (Tadalafil Tablets Usp 5)

A line graph showing plasma tadalafil concentration (mcg/L) over time (hours) for different dosing regimens: single 20-mg dose, single 5-mg dose, and once-daily 5-mg dose following 5 consecutive days of administration. Concentrations peak early and decline over time, with distinct profiles for each regimen.*

FDA Label Image

10 (Tadalafil Tablets Usp 6)

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

FDA Label Image

10 (Tadalafil Tablets Usp 7)

A line graph comparing change from baseline in IPSS total score over 12 weeks between Tadalafil 5 mg and placebo groups. The x-axis represents duration of treatment in weeks, and the y-axis shows change in IPSS score. Tadalafil shows a greater decrease in score over time compared to placebo, with statistically significant differences at 4 and 12 weeks (p<0.01).*

FDA Label Image

10 (Tadalafil Tablets Usp 8)

A line graph depicting the least squares mean change from baseline over weeks of therapy (0, 4, 12, 26) for two groups: Tadalafil/Finasteride and Placebo/Finasteride. The graph shows a greater decrease for Tadalafil/Finasteride compared to Placebo/Finasteride, with statistical significance noted at weeks 4, 12, and 26.*

FDA Label Image

10 (Tadalafil Tablets Usp 9)

A line graph comparing the change from baseline in IPSS total score over a 12-week treatment period for Tadalafil 5 mg versus placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows change from baseline scores, with Tadalafil showing a greater decrease over time compared to placebo. Data points are marked with circles for Tadalafil and triangles for placebo.*

* 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.