Tadalafil Tablet
Product Images NDC 70518-3931

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 70518-3931). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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

Remedy_label (Remedy Label)

Tadalafil 20 mg tablet label showing quantity of 12 tablets. The label includes the proprietary name Tadalafil, dosage strength 20 mg, and labeler RemedyRepack Inc. It also includes manufacturer information as Solco, Cranbury, NJ, and storage instructions for temperature. Barcodes and a QR code are visible, along with a warning to keep medication out of reach of children.*

FDA Label Image

Ab0f57c0-figure-01 (Ab0f57c0 Figure 01)

Chemical structure diagram of tadalafil showing its molecular framework, including rings and functional groups, as presented in the image.*

FDA Label Image

Ab0f57c0-figure-02 (Ab0f57c0 Figure 02)

A line graph comparing mean change from baseline (in meters) over 16 weeks between placebo and tadalafil tablets 40 mg groups. The timeline is shown in weeks on the x-axis, with measurements at 0, 4, 8, 12, and 16 weeks. The tadalafil group shows a progressive increase, whereas the placebo group remains relatively flat. Statistical significance is indicated at multiple points with p-values noted in the legend.*

FDA Label Image

Ab0f57c0-figure-03 (Ab0f57c0 Figure 03)

A horizontal bar chart depicting placebo-adjusted mean change in 6-minute walk distance (meters) for Tadalafil 40 mg tablets versus placebo across various subgroups of subjects with pulmonary arterial hypertension. The chart includes subgroups based on Bosentan use, PAH etiology, baseline 6-minute walk distance, gender, age, and baseline WHO functional class, with 95% confidence intervals shown for each subgroup.*

FDA Label Image

Ab0f57c0-figure-04 (Ab0f57c0 Figure 04)

A line graph depicting the percentage without clinical worsening over time in days for three groups: tadalafil tablets 40 mg, tadalafil tablets 20 mg, and placebo. The x-axis represents time to clinical worsening in days (0 to 150), and the y-axis shows the percentage without clinical worsening (0 to 100%). Three lines illustrate the trend for each group across the time period.*

FDA Label Image

Figure 1 (Image 01)

A forest plot graph illustrating the mean difference in blood pressure measurements (systolic and diastolic) for tadalafil 20 mg and 10 mg tablets, compared to placebo, under various coadministered drug conditions. The x-axis represents mean difference relative to placebo from -20 to 20, with confidence intervals shown for each drug combination and measurement type.*

FDA Label Image

Figure 2 (Image 02)

A chart depicting fold change and 90% confidence intervals for various coadministered drugs relative to tadalafil alone. It includes CYP3A inhibitors (ritonavir, ketoconazole), CYP3A inducers (rifampin, bosentan), antacids (magnesium hydroxide/aluminum hydroxide), and H2 antagonists (nizatidine) with recommendations for dose adjustment or avoidance. The x-axis represents change relative to tadalafil alone on a scale from 0 to 5.*

FDA Label Image

Figure3 (Image 03)

A chart showing fold change and 90% confidence intervals for various coadministered drugs compared to the drug alone. It lists multiple substrates including CYP1A2, CYP2C9, CYP3A, P-glycoprotein, oral contraceptives, and NSAIDs, and shows that no dose adjustments are recommended for each. The x-axis represents change relative to the coadministered drug alone, ranging from 0.00 to 2.00.*

* 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.