Tadalafil
Product Images NDC 71455-597

Product Visual Gallery

This gallery contains 33 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71455-597). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unyter Enterprises, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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20mg Tadalafil (20mg Tadalafil Label)

Label for TADALAFIL tablets USP 20 mg from UNYTER ENTERPRISES. The package contains 10 tablets. The National Drug Code (NDC) is 71455-0597-10. The label includes storage instructions to keep at 20°-25°C (68°-77°F) and notes that it is Rx only. The label mentions dispensing the accompanying medication guide to each patient.*

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Figure 1 (Figure 1)

Four line graphs showing the difference in blood pressure measurements (standing systolic, standing diastolic, supine systolic, supine diastolic) comparing Tadalafil to placebo over time (0 to 96 hours). Each graph plots difference in mmHg on the vertical axis against time in hours on the horizontal axis, with error bars indicating variability.*

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Figure 2 (Figure 2)

Two line graphs showing changes in systolic blood pressure over 24 hours post-dose. The top graph measures standing systolic BP, and the bottom graph measures supine systolic BP. Both compare Tadalafil 20 mg & doxazosin 8 mg (solid line) versus placebo & doxazosin 8 mg (dotted line). Time post-dose in hours is on the x-axis; BP change in mmHg is on the y-axis.*

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Figure 3 (Figure 3)

A line graph depicting changes in systolic blood pressure (mmHg) over 12 hours after administration of tadalafil or placebo combined with doxazosin. The graph shows four lines representing 20 mg tadalafil at 08:00 and 20:00, and placebo at both times, all combined with 8 mg qd doxazosin. The x-axis shows time in hours, and the y-axis shows systolic BP changes in mmHg.*

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Figure 4 (Figure 4)

A pharmacokinetic line graph showing plasma tadalafil concentration (µg/L) over time (hours). It compares three dosing regimens: a single 20-mg dose, a single 5-mg dose, and once-daily 5-mg dosing after 5 days. The graph illustrates how concentration changes post-dose with error bars for variability.*

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Figure 5 (Figure 5)

A line graph illustrating the change from baseline in IPSS total score over 12 weeks of treatment. Two lines represent tadalafil 5 mg and placebo groups, showing a greater decrease in IPSS score for tadalafil 5 mg. The x-axis indicates treatment duration in weeks, and the y-axis shows change from baseline in the score, with a statistically significant difference (p<0.01) noted at 12 weeks.*

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Figure 6 (Figure 6)

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 graph shows greater reduction in IPSS score with tadalafil 5 mg at multiple time points, with statistical significance marked at p<0.01.*

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Figure 7 (Figure 7)

A line graph comparing the least squares mean change from baseline over 26 weeks of therapy between Tadalafil/Finasteride and Placebo/Finasteride treatments. The x-axis shows weeks of therapy (0, 4, 12, 26), and the y-axis shows LS mean change values. Statistical significance markers for p<0.001 and p<0.05 are indicated at various points on the graph.*

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Figure 8 (Figure 8)

A line chart showing change from baseline in IPSS total score over treatment duration in weeks. It compares tadalafil 5 mg with placebo, displaying a greater reduction in score for tadalafil across 12 weeks. The chart includes symbols for statistical significance (p<0.01).*

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Table 1 (Table 1)

A data table listing treatment-emergent adverse reactions reported by at least 2% of patients treated with Tadalafil at doses of 5 mg, 10 mg, and 20 mg, compared to placebo, from eight primary placebo-controlled clinical studies. Reactions include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb, with percentage incidences given for each group.*

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Table 10 (Table 10)

A data table titled 'Table 10: Alfuzosin (10 mg/day) Study: Mean Maximal Decrease (95% CI) in Systolic Blood Pressure' showing placebo-subtracted mean maximal decrease in systolic blood pressure (mm Hg). It compares the effects of Tadalafil 20 mg in supine and standing positions, with values of 2.2 (-0.9, -5.2) and 4.4 (-0.2, 8.9) respectively.*

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Table 11 (Table 11)

A data table titled 'Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Primary US Trials' comparing placebo and Tadalafil 20 mg in Study A and Study B. It shows endpoints and changes from baseline for EF Domain Score, Insertion of Penis (SEP2), and Maintenance of Erection (SEP3) with sample sizes and p-values.*

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Table 12 (Table 12)

A data table titled 'Table 12: Mean Endpoint and Change from Baseline for the EF Domain of the IIEF in the General ED Population in Five Primary Trials Outside the US.' The table compares placebo and three dosages of Tadalafil (5 mg, 10 mg, 20 mg) across five studies (C, D, E, F, G) showing mean endpoint values and changes from baseline with associated p-values indicating statistical significance in some cells.*

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Table 13 (Table 13)

A data table titled 'Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 2' showing success rates for placebo and Tadalafil doses (5 mg, 10 mg, 20 mg) across five pivotal studies (C, D, E, F, G) outside the US. It lists endpoint success rates and changes from baseline with statistical p-values for each study and dosage. Study F has a footnote indicating a 6-month treatment duration.*

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Table 14 (Table 14)

A data table titled 'Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 3 in the General ED Population in Five Pivotal Trials Outside the US.' It compares success rates for Placebo and Tadalafil at 5 mg, 10 mg, and 20 mg doses across studies C, D, E, F, and G, showing percentage endpoints and changes from baseline, with significance p-values noted. Treatment duration in Study F is 6 months.*

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Table 15 (Table 15)

A data table titled 'Table 15: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study in ED Patients with Diabetes.' It presents comparative results for placebo, Tadalafil 10 mg, and Tadalafil 20 mg groups (with respective sample sizes). The table includes EF domain score, insertion of penis (SEP2), and maintenance of erection (SEP3) endpoints with numerical values and changes from baseline, alongside p-values indicating statistical significance.*

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Table 16 (Table 16)

A clinical data table showing mean endpoint and change from baseline for primary efficacy variables in a study on erectile dysfunction following bilateral nerve-sparing radical prostatectomy. The table compares placebo (N=102) and Tadalafil 20 mg (N=201) groups across EF Domain Score, Insertion of Penis (SEP2), and Maintenance of Erection (SEP3) with corresponding p-values indicating statistical significance.*

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Table 17 (Table 17)

Table presents mean endpoint values and change from baseline for primary efficacy variables in two tadalafil once-daily use studies (Study H and Study I). Data include EF Domain Score, Insertion of Penis (SEP2), and Maintenance of Erection (SEP3) endpoints and changes, comparing placebo with tadalafil 2.5 mg and 5 mg doses, with p-values indicating statistical significance.*

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Table 18 (Table 18)

Data table titled 'Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil for Once Daily Use Study in ED Patients with Diabetes.' It compares placebo, Tadalafil 2.5 mg, and Tadalafil 5 mg (each with sample sizes) across EF Domain Score, Insertion of Penis (SEP2), and Maintenance of Erection (SEP3), showing endpoint percentages and changes from baseline with p-values indicating statistical significance.*

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Table 19 (Table 19)

A data table titled 'Mean IPSS Changes in BPH Patients in Two Tadalafil for Once Daily Use Studies' showing baseline and change from baseline to week 12 total symptom scores (IPSS) for placebo and Tadalafil 5 mg groups in two studies (Study J and Study K). It includes participant numbers (N) and p-values for the results.*

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Table 2 (Table 2)

Table showing treatment-emergent adverse reactions reported by 2% or more of patients treated with Tadalafil 2.5 mg or 5 mg daily compared to placebo in three placebo-controlled Phase 3 studies for erectile dysfunction. Reactions listed include headache, dyspepsia, nasopharyngitis, back pain, upper respiratory tract infection, flushing, myalgia, cough, diarrhea, nasal congestion, pain in extremity, urinary tract infection, gastroesophageal reflux disease, and abdominal pain.*

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Table 20 (Table 20)

A data table titled 'Table 20: Mean IPSS Changes in BPH Patients in a Tadalafil for Once Daily Use Study Together with Finasteride.' It compares symptom score changes over time between placebo plus finasteride 5 mg and tadalafil 5 mg plus finasteride 5 mg groups, showing sample sizes, mean baseline scores, changes from baseline at weeks 4, 12, and 26, treatment differences, and p-values.*

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Table 21 (Table 21)

Data table titled 'Mean IPSS and IIEF EF Domain Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH' comparing Placebo and Tadalafil 5 mg groups. It shows Total Symptom Score (IPSS) and EF Domain Score (IIEF EF) at baseline and changes at Week 12, including sample sizes, baseline, endpoint (for EF Domain), change values, and p-values.*

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Table 22 (Table 22)

Table showing mean SEP Question 3 changes in a Tadalafil 5 mg once daily use study for patients with ED and BPH, comparing placebo (N=187) and Tadalafil 5 mg (N=199). It presents baseline, endpoint, and change from baseline to week 12 for Maintenance of Erection (SEP3), with percentages and a p-value for change.*

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Table 3 (Table 3)

Data table listing treatment-emergent adverse reactions reported by 2% or more of patients treated with Tadalafil for once daily use at 2.5 mg and 5 mg doses, compared with placebo, in a 24-week placebo-controlled clinical study for erectile dysfunction (ED). The table includes adverse reactions such as nasopharyngitis, gastroenteritis, back pain, upper respiratory tract infection, dyspepsia, gastroesophageal reflux disease, myalgia, hypertension, and nasal congestion with percentage incidences for placebo, Tadalafil 2.5 mg, and Tadalafil 5 mg groups.*

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Table 4 (Table 4)

A data table showing treatment-emergent adverse reactions reported by 1% or more of patients treated with Tadalafil 5 mg versus placebo in three placebo-controlled clinical studies of 12 weeks. The table lists adverse reactions including headache, dyspepsia, back pain, nasopharyngitis, diarrhea, pain in extremity, myalgia, and dizziness, along with the percentage incidence in placebo and Tadalafil groups.*

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Table 5 (Table 5)

A data table titled 'Table 5: Doxazosin (8 mg/day) Study 1: Mean Maximal Decrease (95% CI) in Systolic Blood Pressure.' It compares the placebo-subtracted mean maximal decrease in systolic blood pressure (mm Hg) for Tadalafil 20 mg in two conditions: supine and standing, showing numerical values with confidence intervals.*

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Table 6 (Table 6)

A data table titled 'Doxazosin (8 mg/day) Study 2 (Part C): Mean Maximal Decrease in Systolic Blood Pressure' showing placebo-subtracted mean maximal decreases in systolic blood pressure (mm Hg). The table compares values for Tadalafil 20 mg taken at 8 a.m. and 8 p.m., listing 7 and 8 mm Hg decreases respectively for ambulatory blood-pressure monitoring (ABPM).*

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Table 7 (Table 7)

A data table titled 'Table 7: Doxazosin Study 3: Mean Maximal Decrease (95% CI) in Systolic Blood Pressure' showing placebo-subtracted mean maximal decrease in systolic blood pressure for Tadalafil 5 mg at Day 1 and Day 7 of 4 mg Doxazosin in supine and standing positions with corresponding confidence intervals.*

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Table 8 (Table 8)

A data table titled 'Tamsulosin (0.4 mg/day) Study 1: Mean Maximal Decrease (95% CI) in Systolic Blood Pressure' showing placebo-subtracted mean maximal decrease in systolic blood pressure (mm Hg) for Tadalafil 10 mg and 20 mg. The table compares values in supine and standing positions with confidence intervals for each dosage.*

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Table 9 (Table 9)

A data table titled 'Study 2: Mean Maximal Decrease (95% CI) in Systolic Blood Pressure' showing placebo-subtracted mean maximal decreases in systolic blood pressure for Tadalafil 5 mg compared to Day 1 and Day 7 of 0.4 mg Tamsulosin in supine and standing positions, with numerical values and confidence intervals listed for each condition.*

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Chemical Structure (Tadalafil Structural Formula)

Chemical structure of Tadalafil showing its molecular framework with characteristic fused ring systems and functional groups.*

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Dbd6b03b 1a8b 0fb7 E053 2a95a90ad0e0

Image of a single yellow, teardrop-shaped tablet imprinted with "F J4" on one side. This corresponds to the drug TADALAFIL by UNYTER ENTERPRISES, although the image does not display strength or additional packaging information.*

* 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.