Alfuzosin Hydrochloride
Product Images NDC 43353-746

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Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Alfuzosin Hydrochloride (NDC 43353-746). 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.

Product Images & Figures Index

FDA Label Image

Bottle Label 10mg (43353 746 30)

Bottle Label 10mg (43353 746 30)
Label for Alfuzosin Hydrochloride Extended Release (ER) Tablets, 10 mg strength, containing 30 tablets. The label shows the product name, dosage strength, quantity, and includes storage instructions. It states the original manufacturer as Mylan Pharmaceuticals Inc., Morgantown, WV, and indicates repackaging by Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN. The label includes the product NDC number 43353-0746-30 and is marked RX Only.*
FDA Label Image

Aphena Pharma Solutions (TN)

Aphena Pharma Solutions (TN)
FDA Label Image

Alfuzosin Hydrochloride Structural Formula (A9ef5385 3416 452b 97ac Cac1b1bdb97f 01)

Alfuzosin Hydrochloride Structural Formula (A9ef5385 3416 452b 97ac Cac1b1bdb97f 01)
Chemical structure of Alfuzosin Hydrochloride, showing the molecular arrangement of atoms including rings, amine groups, and methoxy groups, with an HCl component indicated.*
FDA Label Image

Figure 1: Mean (sem) Alfuzosin Plasma Concentration-time Profiles After A Single Administration Of Alfuzosin Hydrochloride Extended-release Tablets 10 mg To Eight Healthy Middle-aged Male Volunteers In Fed And Fasted States (A9ef5385 3416 452b 97ac Cac1b1bdb97f 02)

Figure 1: Mean (sem) Alfuzosin Plasma Concentration-time Profiles After A Single Administration Of Alfuzosin Hydrochloride Extended-release Tablets 10 mg To Eight Healthy Middle-aged Male Volunteers In Fed And Fasted States (A9ef5385 3416 452b 97ac Cac1b1bdb97f 02)
A line graph depicting alfuzosin plasma concentration (ng/mL) over a 24-hour period comparing fed and fasted states. The x-axis represents time in hours, and the y-axis shows alfuzosin plasma concentration. Two lines with error bars illustrate higher concentrations under fed conditions compared to fasted.*
FDA Label Image

Figure 2: Mean Change From Baseline In Ipss Total Symptom Score: Trial 1 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 03)

Figure 2: Mean Change From Baseline In Ipss Total Symptom Score: Trial 1 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 03)
A line graph depicting mean change over days of treatment comparing Placebo (N=167) and Alfuzosin HCl ER (N=170). The x-axis shows days of treatment (0, 28, 56, 84), while the y-axis shows mean change values. The Alfuzosin HCl ER group shows a greater decline in mean change than the Placebo group over time, with statistical significance noted at day 84 (p < 0.001).*
FDA Label Image

Figure 3: Mean Change From Baseline In Ipss Total Symptom Score: Trial 2 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 04)

Figure 3: Mean Change From Baseline In Ipss Total Symptom Score: Trial 2 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 04)
A line graph comparing the mean change over days of treatment between placebo and Alfuzosin HCl ER groups. The X-axis represents days of treatment (0, 28, 56, 84), and the Y-axis shows mean change. The graph indicates greater mean change for Alfuzosin HCl ER compared to placebo over time, with statistical significance noted at day 84 (p < 0.01).*
FDA Label Image

Figure 4: Mean Change From Baseline In Ipss Total Symptom Score: Trial 3 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 05)

Figure 4: Mean Change From Baseline In Ipss Total Symptom Score: Trial 3 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 05)
A line chart comparing the mean change over days of treatment between a placebo group (N=150) and Alfuzosin HCl ER group (N=151). The x-axis represents days of treatment (0, 28, 56, 84), and the y-axis represents mean change. The graph shows greater mean change reduction in the Alfuzosin HCl ER group compared to placebo, with statistical significance at day 84 (p < 0.01).*
FDA Label Image

Figure 5: Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 1 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 06)

Figure 5: Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 1 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 06)
A line graph comparing the mean change in mL/s over days of treatment (0, 28, 56, 84) for placebo (N=167) and Alfuzosin HCl ER (N=170). Alfuzosin HCl ER shows a marked increase compared to placebo, with significant differences indicated (p < 0.001).*
FDA Label Image

Figure 6: Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 2 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 07)

Figure 6: Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 2 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 07)
A line graph showing mean change in mL/s over days of treatment comparing Alfuzosin HCl ER (N=136) and placebo (N=147). The graph shows an increase over 84 days, with Alfuzosin HCl ER having greater improvement than placebo, statistically significant at day 84 (p < 0.05).*
FDA Label Image

Figure 7: Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 3 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 08)

Figure 7: Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 3 (A9ef5385 3416 452b 97ac Cac1b1bdb97f 08)
A line graph comparing the mean change (in mL/s) over days of treatment between a placebo group (N=150) and an Alfuzosin Hydrochloride extended-release group (N=151). The graph shows measurements at 0, 14, 28, 56, and 84 days, with Alfuzosin HCl ER showing a higher mean change than placebo throughout, and a note indicating non-significant difference (NS) at day 84 with p > 0.05.*

* 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.