Tadalafil Tablet, Film Coated
Product Images NDC 76420-126

11 FDA label images from Asclemed Usa, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 76420-126). 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

Figure (Tadalafil Figure1)

Figure (Tadalafil Figure1)
A set of four line graphs showing the difference in blood pressure measurements over time between Tadalafil and placebo. The graphs present standing systolic and diastolic blood pressure, and supine systolic and diastolic blood pressure, with time on the x-axis (0 to 96 hours) and blood pressure difference in mmHg on the y-axis. Error bars are included for each data point.*
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Figure (Tadalafil Figure2)

Figure (Tadalafil Figure2)
Two line graphs showing the effect of Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg on systolic blood pressure over time. The top graph measures standing systolic BP (mmHg) and the bottom graph measures supine systolic BP (mmHg), both plotted against hours post-dose (0 to 24). Tadalafil plus doxazosin shows more pronounced initial BP decrease compared to placebo.*
FDA Label Image

Figure (Tadalafil Figure3)

Figure (Tadalafil Figure3)
A line graph depicting systolic blood pressure (mmHg) changes over 12 hours following administration of tadalafil or placebo combined with doxazosin. Four lines represent 20 mg tadalafil at 08:00 and 20:00 with 8 mg doxazosin, and corresponding placebo groups, tracking blood pressure variations over time.*
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Figure (Tadalafil Figure4)

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 once-daily 5-mg dosing following five consecutive days of administration. Concentration peaks early and declines over time with error bars for variability.*
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Figure 5 (Tadalafil Figure5)

Figure 5 (Tadalafil Figure5)
A line graph comparing changes from baseline in IPSS total score over 12 weeks of treatment between tadalafil 5 mg and placebo groups. The x-axis shows duration of treatment (weeks: 0, 4, 8, 12), while the y-axis shows change from baseline in IPSS total score. Two lines represent tadalafil 5 mg (solid line with dots) and placebo (dashed line with triangles). Tadalafil shows a greater decrease in score over time compared to placebo, with significance noted at 12 weeks.*
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Figure 6 (Tadalafil Figure6)

Figure 6 (Tadalafil Figure6)
A line graph showing the change from baseline in IPSS Total Score over a 12-week treatment duration comparing tadalafil 5 mg and placebo. The graph indicates that tadalafil 5 mg results in a greater reduction in IPSS score compared to placebo, with significant differences marked at specific time points.*
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Figure 7 (Tadalafil Figure7)

Figure 7 (Tadalafil Figure7)
A line graph showing the least squares mean change from baseline over 26 weeks of therapy comparing Tadalafil/Finasteride and Placebo/Finasteride treatments. The x-axis represents weeks of therapy (0, 4, 12, 26), and the y-axis represents the least squares mean change from baseline. Data points indicate greater reduction with Tadalafil/Finasteride at weeks 4, 12, and 26, with statistical significance noted (p<0.001, p<0.05).*
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Figure 8 (Tadalafil Figure8)

Figure 8 (Tadalafil Figure8)
A line graph comparing the change from baseline in IPSS total score over a 12-week treatment duration, showing results for tadalafil 5 mg versus placebo. The x-axis represents weeks of treatment, and the y-axis shows the change in score, with tadalafil demonstrating greater improvement compared to placebo. Statistical significance is noted at some points (p<0.01).*
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Tadalafil Tablets, Usp 5 mg (Label)

Tadalafil Tablets, Usp 5 mg (Label)
Two relabeling pharmaceutical labels for Tadalafil Tablets, USP 5 mg, film-coated tablets by Asclemed USA, Inc. The labels show two package quantities: 30 and 90 tablets. Both labels include the NDC numbers 76420-126-30 and 76420-126-90 respectively, mention the prescribing status (RX), and storage instructions at controlled room temperature (20-25°C). Manufacturer noted is Accord Healthcare, Inc., with relabeling by Enovachem Pharmaceuticals in Torrance, CA.*
FDA Label Image

Tadalafil Tablets, Usp (Label)

Tadalafil Tablets, Usp (Label)
Packaging labels for Tadalafil Tablets, USP 5 mg film-coated tablets by Enovachem Pharmaceuticals. The labels show three package sizes: 15 count (NDC 76420-126-15), 30 count (NDC 76420-126-30), and 90 count (NDC 76420-126-90). Each label includes manufacturing information, storage instructions, and barcodes including QR codes. The labels list Accord Healthcare, Inc. as the manufacturer.*
FDA Label Image

Chemical Structure (Tadalafil Structure)

Chemical Structure (Tadalafil Structure)
Chemical structure of Tadalafil, the active ingredient depicted as a complex arrangement of rings and bonds consistent with its molecular composition.*

* 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.