Tadalafil Tablet, Film Coated
Product Images NDC 68071-2553

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 68071-2553). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare 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.

FDA Label Image

Pdp (68071 2553 3)

Tadalafil 20 mg film-coated tablets label from NuCare Pharmaceuticals, Inc. The label indicates a package containing 30 tablets, with the product number R1856030 and NDC 68071-2553-3. It includes instructions to see the manufacturer's label for ingredients, warnings to keep out of reach of children, and storage conditions at controlled temperature 68-77°F. The label also features barcodes, lot, serial, and expiration number placeholders, and contact information for reporting side effects to the FDA.*

FDA Label Image

Figure (Tadalafil Figure1)

A set of four line graphs depicting the effect of Tadalafil versus placebo on blood pressure over time up to 96 hours. The graphs show differences in standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure, with values on the y-axis (mmHg) and time on the x-axis (hours). Error bars indicate variability at each time point.*

FDA Label Image

Figure (Tadalafil Figure2)

Two line graphs depicting the change in systolic blood pressure (BP) over 24 hours post-dose. The top graph shows standing systolic BP changes, and the bottom graph shows supine systolic BP changes. Data are compared for Tadalafil 20 mg with doxazosin 8 mg (solid line) versus placebo with doxazosin 8 mg (dotted line). Both graphs show BP values in mmHg on the vertical axis and time in hours on the horizontal axis.*

FDA Label Image

Figure (Tadalafil Figure3)

A line graph depicting changes in systolic blood pressure (mmHg) over 12 hours following administration of tadalafil or placebo combined with doxazosin. The x-axis represents time after administration in hours, while the y-axis shows systolic blood pressure changes. Four data series compare 20 mg tadalafil at 08:00 and 20:00 versus placebo, each combined with 8 mg doxazosin at 08:00.*

FDA Label Image

Figure (Tadalafil Figure4)

A line graph showing plasma tadalafil concentration (µg/L) over time (hours) for three dosing regimens: a single 20-mg dose, a single 5-mg dose, and a once-daily 5-mg dose following 5 consecutive days of administration. Concentration peaks occur shortly after dosing, then decline over time for each regimen, with error bars representing data variability.*

FDA Label Image

Figure 5 (Tadalafil Figure5)

A line graph depicting changes from baseline in IPSS total score over a 12-week treatment period comparing tadalafil 5 mg and placebo. The x-axis represents treatment duration in weeks, and the y-axis shows change in IPSS score. The tadalafil 5 mg group shows a greater and statistically significant decrease in IPSS score compared to placebo.*

FDA Label Image

Figure 6 (Tadalafil Figure6)

A line graph showing the 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, 1, 4, 8, 12), and the y-axis represents change from baseline in IPSS total score, with tadalafil showing a greater decrease over time compared to placebo.*

FDA Label Image

Figure 7 (Tadalafil Figure7)

A line graph depicting the least-squares mean change from baseline over weeks of therapy for two groups: Tadalafil/Finasteride and Placebo/Finasteride. The x-axis shows weeks of therapy (0,4,12,26) and the y-axis shows LS Mean Change from Baseline, ranging from 0 to -7. Data points for each group show greater reduction in the Tadalafil/Finasteride group compared to Placebo/Finasteride at each time point, with statistical significance annotations (p<0.001 and p<0.05) indicated below some points.*

FDA Label Image

Figure 8 (Tadalafil Figure8)

A line graph showing change from baseline in IPSS Total Score over treatment duration in weeks. Two lines compare tadalafil 5 mg and placebo groups, depicting greater score reduction over time with tadalafil, indicating efficacy differences between treatment and placebo.*

FDA Label Image

Chemical Structure (Tadalafil Structure)

Chemical structure diagram of the active ingredient tadalafil, showing its molecular framework with indole and lactam ring systems and a benzodioxole moiety.*

* 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.