Tadalafil
Product Images NDC 71610-325

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71610-325). 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 0324 08)

Tadalafil USP 5 mg tablet bottle label from Aphena Pharma Solutions - Tennessee, LLC. The label includes storage instructions, manufacturer information (Sun Pharmaceutical Ind. Ltd.), packaging origin (Dadra, India), and NDC 71610-0324-08. The label states the tablet count as 8 and cautions to keep out of reach of children.*

FDA Label Image

Bottle Label 20 mg (71610 0325 04)

Label for Tadalafil USP 20 mg tablets, pack of 4. The label includes storage instructions to keep between 20-25 degrees Celsius and to dispense in a tight light-resistant container. Manufactured by Sun Pharmaceutical Industries Ltd. in India and packaged by Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN. The label also includes handling precautions and an NDC number.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Spl-tadalafil-figure-1 (Spl Tadalafil Figure 1)

Set of four line graphs showing the effect of Tadalafil versus placebo on standing and supine systolic and diastolic blood pressure over time in hours. Each graph plots the difference in blood pressure (mmHg) on the y-axis against time (0 to 96 hours) on the x-axis with error bars included.*

FDA Label Image

Spl-tadalafil-figure-2 (Spl Tadalafil Figure 2)

A line graph chart showing the change in standing and supine systolic blood pressure (mmHg) over a 24-hour period after dosing. Two lines represent treatment groups: Tadalafil 20 mg with doxazosin 8 mg and placebo with doxazosin 8 mg. The x-axis shows time post-dose in hours, and the y-axis shows systolic blood pressure changes.*

FDA Label Image

Spl-tadalafil-figure-3 (Spl Tadalafil Figure 3)

A line graph illustrating the effect of 20 mg tadalafil versus placebo on systolic blood pressure (mmHg) over 12 hours when administered with 8 mg doxazosin at 08:00. The graph includes four conditions: tadalafil and placebo given at 08:00 with doxazosin, and tadalafil and placebo given at 20:00 with doxazosin, showing fluctuations in systolic blood pressure over time.*

FDA Label Image

Spl-tadalafil-figure-4 (Spl Tadalafil Figure 4)

A line graph depicting plasma tadalafil concentration (µg/L) over time (hours) following administration of different tadalafil doses. The graph compares single 20-mg and 5-mg doses, and once-daily 5-mg doses after 5 days, showing concentration trends and variability with error bars.*

FDA Label Image

Spl-tadalafil-figure-5 (Spl Tadalafil Figure 5)

A line graph showing change from baseline in IPSS total score over 12 weeks of treatment comparing Tadalafil 5 mg and placebo. The y-axis represents change in IPSS total score, and the x-axis shows treatment duration in weeks (0, 4, 8, 12). Tadalafil 5 mg shows a greater decrease in score over time than placebo, with statistically significant difference at 12 weeks.*

FDA Label Image

Spl-tadalafil-figure-6 (Spl Tadalafil Figure 6)

A line graph showing change from baseline in IPSS Total Score over a 12-week treatment duration. It compares Tadalafil 5 mg (solid line with solid circles) versus placebo (dashed line with open triangles), indicating greater score reduction with Tadalafil. Statistically significant differences (*) are marked at weeks 4 and 12.*

FDA Label Image

Spl-tadalafil-figure-8 (Spl Tadalafil Figure 8)

A line graph comparing change from baseline in IPSS total score over 12 weeks of treatment, showing data for Tadalafil 5 mg versus placebo. The y-axis represents change from baseline, and the x-axis shows duration of treatment in weeks. The chart includes a statistical significance marker for Tadalafil at week 12.*

FDA Label Image

Spl-tadalafil-structure (Spl Tadalafil Structure)

Chemical structure of Tadalafil, showing its fused ring system including a piperazine ring with keto and methyl groups, an indole ring, and a methylenedioxybenzene 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.