Tadalafil
Product Images NDC 71610-354

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71610-354). 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 20 mg (71610 0353 04)

Tadalafil 20mg tablets label showing the active ingredient strength and dosage form. The label includes storage instructions, manufacturer information listing Teva Pharmaceutical Ind Ltd in Jerusalem, Israel, and repackager Aphena Pharma Solutions in Cookeville, Tennessee. It also contains NDC number 71610-0353-04 and RX only designation.*

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Bottle Label 5 mg (71610 0354 23)

Tadalafil USP label for 16 tablets with 5 mg strength. The label includes storage instructions, manufacturer Teva Pharmaceutical Industries Ltd in Jerusalem, Israel, and labeler Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. It also notes the product is for Rx use only and instructs to keep out of reach of children.*

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Aphena Pharma Solutions (TN)

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Tadalafil Structural Formula (Tadalafil Tabs 090141 1)

Chemical structure diagram of Tadalafil showing its molecular framework with various rings and functional groups as depicted in the image, corresponding to the active ingredient in the product by Aphena Pharma Solutions - Tennessee, LLC.*

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Figure 1: Mean Maximal Change In Blood Pressure (tadalafil Minus Placebo, Point Estimate With 90% Ci) In Response To Sublingual Nitroglycerin At 2 (supine Only), 4, 8, 24, 48, 72, And 96 Hours After T (Tadalafil Tabs 090141 2)

Four line graphs depicting the effect of Tadalafil versus placebo on blood pressure over time. The graphs show changes in standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure measured as differences from placebo (mmHg) at multiple time points up to 96 hours.*

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Figure 2: Doxazosin Study 1: Mean Change From Baseline In Systolic Blood Pressure (Tadalafil Tabs 090141 3)

Two line graphs showing standing and supine systolic blood pressure (BP) changes over 24 hours post-dose in mmHg. The top graph compares standing systolic BP for Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg. The bottom graph shows supine systolic BP changes for the same groups over time in hours.*

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Figure 3: Doxazosin Study 2 (part C): Mean Change From Time-matched Baseline In Systolic Blood Pressure (Tadalafil Tabs 090141 4)

A line graph showing the effect over time on systolic blood pressure (mmHg) after administration of 20 mg tadalafil and 8 mg doxazosin compared to placebo. The x-axis represents time after administration in hours, up to 12 hours, with separate lines for morning (08:00) and evening (20:00) dosing.*

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Figure 4: Plasma Tadalafil Concentrations (mean ± Sd) Following A Single 20 mg Tadalafil Dose And Single And Once Daily Multiple Doses Of 5 mg (Tadalafil Tabs 090141 5)

A pharmacokinetic line graph showing plasma tadalafil concentration (mcg/L) over time (hours). It compares single doses of 20 mg and 5 mg tadalafil with once-daily 5 mg tadalafil after 5 days of administration, displaying drug concentration changes and error bars at various time points up to 120 hours.*

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Figure 5: Mean Ipss Changes In Bph Patients By Visit In Study J (Tadalafil Tabs 090141 6)

A line graph showing the change from baseline in IPSS total score over 12 weeks of treatment. It compares two groups: Tadalafil 5 mg and placebo, with the Tadalafil group showing a greater decrease in score over time. Statistically significant differences are indicated (p < 0.01).*

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Figure 6: Mean Ipss Changes In Bph Patients By Visit In Study K (Tadalafil Tabs 090141 7)

A line graph comparing the change from baseline in IPSS total score over a 12-week treatment period for Tadalafil 5 mg versus placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows change from baseline, with Tadalafil showing a greater score reduction than placebo at several points, including statistically significant differences at weeks 4 and 12 (p<0.01).*

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Figure 7: Mean Total Ipss Changes By Visit In Bph Patients Taking Tadalafil For Once Daily Use Together With Finasteride (Tadalafil Tabs 090141 8)

A line graph showing least-squares mean change from baseline over 26 weeks of therapy. It compares Tadalafil/Finasteride (solid line) with Placebo/Finasteride (dashed line) at 0, 4, 12, and 26 weeks. The graph includes notes on statistical significance (p-values) and shows decreasing values for both groups, with Tadalafil/Finasteride consistently lower.*

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Figure 8: Mean Ipss Changes In Ed/bph Patients By Visit In Study L (Tadalafil Tabs 090141 9)

Line graph comparing change from baseline in IPSS total score over 12 weeks of treatment between Tadalafil 5 mg and placebo groups. The x-axis represents duration of treatment in weeks, and the y-axis shows change from baseline score. Tadalafil group shows a greater decrease over time, with statistical significance indicated at 12 weeks (p<0.01).*

* 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.