Alfuzosin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 57237-114

9 FDA label images from Rising Pharma Holdings, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Alfuzosin Hydrochloride (NDC 57237-114). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, 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 1 (Alfuzosin Fig1)

Figure 1 (Alfuzosin Fig1)
A line graph showing mean alfuzosin plasma concentration (ng/mL) over 24 hours post single oral dose of 10 mg alfuzosin hydrochloride extended-release tablets. Two profiles compare fed and fasted states in healthy middle-aged male volunteers, with concentration rising faster and higher in fed state, then declining over time. Error bars represent SEM.*
FDA Label Image

Figure 2 — Mean Change From Baseline In Ipss Total Symptom Score: Trial 1 (Alfuzosin Fig2)

Figure 2 — Mean Change From Baseline In Ipss Total Symptom Score: Trial 1 (Alfuzosin Fig2)
A line graph comparing mean change from baseline in IPSS total symptom score over days of treatment between placebo and Alfuzosin Hydrochloride groups. The x-axis shows days of treatment (0, 28, 56, 84), and the y-axis shows mean change. Alfuzosin Hydrochloride group shows a greater reduction over time compared to placebo, with statistical significance indicated (p < 0.001).*
FDA Label Image

Figure 3 — Mean Change From Baseline In Ipss Total Symptom Score: Trial 2 (Alfuzosin Fig3)

Figure 3 — Mean Change From Baseline In Ipss Total Symptom Score: Trial 2 (Alfuzosin Fig3)
A line graph depicting the mean change from baseline in IPSS total symptom score over 84 days of treatment. The graph compares two groups: placebo (N=152) and Alfuzosin Hydrochloride (N=137). The Alfuzosin group shows a greater reduction in symptom score compared to placebo, with data points shown at days 0, 28, 56, and 84.*
FDA Label Image

Figure 4 — Mean Change From Baseline In Ipss Total Symptom Score: Trial 3 (Alfuzosin Fig4)

Figure 4 — Mean Change From Baseline In Ipss Total Symptom Score: Trial 3 (Alfuzosin Fig4)
A line graph showing the mean change from baseline in IPSS Total Symptom Score over 84 days of treatment comparing placebo and Alfuzosin Hydrochloride. The x-axis represents days of treatment (0, 28, 56, 84), and the y-axis shows mean change values, with Alfuzosin Hydrochloride showing greater symptom score reduction than placebo. Statistical significance (p < 0.01) is noted.*
FDA Label Image

Figure 5 — Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 1 (Alfuzosin Fig5)

Figure 5 — Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 1 (Alfuzosin Fig5)
A line graph depicting the mean change from baseline in peak urine flow rate (mL/s) over days of treatment for two groups: placebo (N=167) and Alfuzosin Hydrochloride (N=170). The graph shows an increasing trend for the Alfuzosin Hydrochloride group, stabilizing after 28 days, while the placebo group remains relatively flat. Statistical significance is indicated at day 84.*
FDA Label Image

Figure 6 — Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 2 (Alfuzosin Fig6)

Figure 6 — Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 2 (Alfuzosin Fig6)
A line graph showing mean change from baseline in peak urine flow rate (mL/s) over 84 days of treatment comparing Alfuzosin Hydrochloride and placebo. The graph tracks mean changes at days 0, 14, 28, 56, and 84, illustrating a higher increase in urine flow rate with Alfuzosin Hydrochloride compared to placebo throughout the treatment period.*
FDA Label Image

Figure 7 — Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 3 (Alfuzosin Fig7)

Figure 7 — Mean Change From Baseline In Peak Urine Flow Rate (ml/s): Trial 3 (Alfuzosin Fig7)
A line graph depicting mean change from baseline in peak urine flow rate (mL/s) over days of treatment for two groups: placebo (N=150) and Alfuzosin Hydrochloride (N=151). The graph shows data points at 0, 14, 28, 56, and 84 days, illustrating a higher increase in peak urine flow rate for the Alfuzosin Hydrochloride group compared to placebo.*
FDA Label Image

Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Package Label-principal Display Panel (10 mg (30 Tablets Bottle))
Label for Alfuzosin Hydrochloride Extended-Release Tablets USP 10 mg, film-coated oral tablets in a package of 90 tablets. The label includes dosage information, storage instructions, and states the product is distributed by Rising Health, LLC and made in India. NDC 57237-114-90, labeler Rising Pharma Holdings, Inc.*
FDA Label Image

Chemical Structure (Alfuzosin Str)

Chemical Structure (Alfuzosin Str)
Chemical structure diagram of Alfuzosin Hydrochloride, showing its molecular components and arrangement including aromatic rings, amine, and hydrochloride salt groups.*

* 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.