Tadalafil Tablet, Film Coated
Product Images NDC 76420-543

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 76420-543). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Asclemed Usa, 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

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

Four line graphs showing changes in blood pressure (systolic and diastolic, standing and supine) over time measured in hours (0 to 96). The y-axis represents the difference in blood pressure (Tadalafil minus placebo) in mmHg, with error bars indicating variability. The graphs illustrate trends in standing systolic and diastolic BP and supine systolic and diastolic BP after Tadalafil administration.*

FDA Label Image

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

Two line graphs showing the effect of Tadalafil 20 mg combined with doxazosin 8 mg compared to placebo with doxazosin 8 mg on systolic blood pressure. The upper graph displays standing systolic blood pressure (mmHg) over 24 hours post-dose, and the lower graph shows supine systolic blood pressure over the same timeframe. Both graphs indicate blood pressure changes relative to time after dosing.*

FDA Label Image

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

A line graph illustrating changes in systolic blood pressure (mmHg) over 12 hours after administration of tadalafil or placebo combined with doxazosin. The graph compares groups receiving 20 mg tadalafil or placebo at 08:00 and 20:00 along with 8 mg daily doxazosin, showing corresponding systolic BP trends over time.*

FDA Label Image

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

A line graph showing plasma tadalafil concentration (µg/L) over time (hours). It compares three dosing regimens: single 20-mg dose, single 5-mg dose, and once-daily 5-mg dose following 5 consecutive days of administration, with data points connected by lines and error bars indicating variability.*

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 oral tablets and placebo. The x-axis represents duration of treatment (weeks), and the y-axis shows change in IPSS score. Tadalafil 5 mg shows a greater decrease in score over time compared to placebo, with a statistically significant difference (p<0.01) at 12 weeks.*

FDA Label Image

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

A line graph comparing the 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 (0, 1, 4, 8, 12), and the y-axis shows the change from baseline in score. Tadalafil 5 mg shows a larger decrease in score than placebo at all measured time points, with statistically significant differences indicated at weeks 4 and 12 (p<0.01).*

FDA Label Image

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

A line chart comparing change from baseline in IPSS total score over 12 weeks of treatment for Tadalafil 5 mg tablets versus placebo. The x-axis shows duration of treatment in weeks (0, 2, 4, 8, 12), and the y-axis shows change from baseline in IPSS total score. Tadalafil 5 mg shows a greater decrease in score over time compared to placebo, with a significant difference noted at 12 weeks (p<0.01).*

FDA Label Image

Spl-tadalafil-label-10mg (Spl Tadalafil Label 10mg)

Label for Tadalafil Tablets USP 10 mg, film-coated, oval-shaped tablets. The label indicates a quantity of 30 tablets, with NDC 76420-543-30. The product is relabeled by Enovachem Pharmaceuticals and manufactured for Northstar Rx, LLC. The label includes cautionary storage instructions and federal dispensing warnings.*

FDA Label Image

Spl-tadalafil-label-20mg (Spl Tadalafil Label 20mg)

Packaging label for Tadalafil Tablets USP 20 mg, film-coated tablets, supplied in a quantity of 30. The label shows the product is relabeled by Enovachem Pharmaceuticals and manufactured for Northstar Rx, LLC. It includes the NDC 76420-544-30 and storage instructions at controlled room temperature.*

FDA Label Image

Spl-tadalafil-label-5mg (Spl Tadalafil Label 5mg)

Packaging label for Tadalafil Tablets, USP 5 mg by Enovachem Pharmaceuticals. The label shows two variations: one with NDC 76420-541-30 for 30 count and another with NDC 76420-541-90 for 90 count. Tablets are described as yellow-colored, oval shaped, biconvex, film-coated with debossed markings. The label also includes the manufacturer Northstar Rx, LLC, storage instructions, and federal law caution about dispensing.*

FDA Label Image

Spl-tadalafil-showbox-1 (Spl Tadalafil Showbox 1)

Label for Tadalafil Tablets USP 2.5 mg, film-coated tablets, packaged in a quantity of 30. The label includes the NDC 76420-542-30, manufacturer Northstar Rx, LLC, and relabeler Enovachem Pharmaceuticals. The label also provides storage instructions and cautions regarding prescription dispensing and child safety.*

FDA Label Image

Spl-tadalafil-structure (Spl Tadalafil Structure)

Chemical structure of the active ingredient tadalafil, showing its fused ring system including a benzodioxole moiety and a methyl-substituted pyrrolidine-2,5-dione ring.*

* 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.