Tamsulosin Hydrochloride Capsule
Product Images NDC 65862-598

8 FDA label images from Aurobindo Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Tamsulosin Hydrochloride (NDC 65862-598). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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 Mean Plasma Tamsulosin Hydrochloride Concentrations Following Single-dose Administration Of Tamsulosin Hydrochloride Capsules 0.4 mg Under Fasted And Fed Conditions (n=8) (Tamsulosin Fig1)

Figure 1 Mean Plasma Tamsulosin Hydrochloride Concentrations Following Single-dose Administration Of Tamsulosin Hydrochloride Capsules 0.4 mg Under Fasted And Fed Conditions (n=8) (Tamsulosin Fig1)
A line graph showing mean plasma concentration of Tamsulosin Hydrochloride over time in hours following single-dose administration of 0.4 mg capsules under fasted and fed conditions. The y-axis represents plasma concentration (ng/mL), and the x-axis represents time (hours). The fasted condition shows a higher peak concentration compared to fed.*
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Figure 2a Mean Change From Baseline In Total Aua Symptom Score (0 To 35) Study 1 (Tamsulosin Fig2)

Figure 2a Mean Change From Baseline In Total Aua Symptom Score (0 To 35) Study 1 (Tamsulosin Fig2)
A line graph depicting mean change from baseline in total AUA symptom score over 13 weeks of treatment. It compares three groups: 0.8 mg dose, 0.4 mg dose, and placebo. The y-axis shows mean change scores, and the x-axis shows treatment duration in weeks. The 0.8 mg and 0.4 mg groups show greater symptom score reductions versus placebo throughout the study.*
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Figure 2b Mean Change From Baseline In Total Aua Symptom Score (0 To 35) Study 2 (Tamsulosin Fig3)

Figure 2b Mean Change From Baseline In Total Aua Symptom Score (0 To 35) Study 2 (Tamsulosin Fig3)
A line graph titled 'Mean Change from Baseline in Total AUA Symptom Score (0 to 35) Study 2' showing mean change on the y-axis and duration of treatment in weeks on the x-axis. It compares three treatments: 0.8 mg, 0.4 mg, and placebo, with data points at weeks 0, 1, 2, 5, 9, and 13. The graph illustrates symptom score changes over time for each treatment group.*
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Figure 3a Mean Increase In Peak Urine Flow Rate (ml/sec) Study 1 (Tamsulosin Fig4)

Figure 3a Mean Increase In Peak Urine Flow Rate (ml/sec) Study 1 (Tamsulosin Fig4)
A line graph titled 'Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 1' showing the mean change in peak urine flow rate over treatment duration in weeks. It compares three treatments: 0.8 mg, 0.4 mg, and placebo, with distinct markers. The y-axis represents mean change in mL/sec from 0 to 3, and the x-axis shows treatment weeks from baseline to 13 weeks and last observed carry forward (LOCF). Sample sizes per time point are noted below the x-axis.*
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Figure 3b Mean Increase In Peak Urine Flow Rate (ml/sec) Study 2 (Tamsulosin Fig5)

Figure 3b Mean Increase In Peak Urine Flow Rate (ml/sec) Study 2 (Tamsulosin Fig5)
A line graph titled 'Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 2' showing treatment effects over 13 weeks. The x-axis represents duration of treatment in weeks from 0 to 13, and the y-axis represents mean change in peak urine flow rate in mL/sec from 0 to 3. Three treatment groups are compared: 0.8 mg, 0.4 mg, and placebo. The 0.8 mg group shows the highest mean increase, peaking around week 2, followed by the 0.4 mg group, with placebo showing minimal change throughout the study.*
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Package Label-principal Display Panel (0.4 mg (100 Capsule Bottle))

Package Label-principal Display Panel (0.4 mg (100 Capsule Bottle))
Label for Tamsulosin Hydrochloride Capsules USP 0.4 mg by Aurobindo Pharma Limited. The label states each capsule contains Tamsulosin hydrochloride USP 0.4 mg and includes storage instructions, usual dosage note, and containers to dispense tightly. The package contains 100 capsules and includes distributor and manufacturing information with a barcode and designated coding area.*
FDA Label Image

Package Label-principal Display Panel (0.4 mg Blister Carton (3 x 10 Unit-dose))

Package Label-principal Display Panel (0.4 mg Blister Carton (3 x 10 Unit-dose))
Label for Tamsulosin Hydrochloride Capsules USP 0.4 mg manufactured by Aurobindo Pharma Limited. The label indicates a package containing 30 capsules (3 x 10 unit-dose). The NDC number 65862-598-10 is shown, and the label includes dosage strength, quantity, and storage instructions in a clear, professional design.*
FDA Label Image

Chemical Structure (Tamsulosin Str)

Chemical Structure (Tamsulosin Str)
Chemical structure of Tamsulosin Hydrochloride showing its molecular composition including sulfur, nitrogen, oxygen, carbon, hydrogen atoms and the hydrochloride group.*

* 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.