Tamsulosin Hydrochloride
Product Images NDC 53217-154

7 FDA label images from Aidarex Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Tamsulosin Hydrochloride (NDC 53217-154). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals 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

Chemical Structure (Tamsulosin HCl Usp 1)

Chemical Structure (Tamsulosin HCl Usp 1)
Chemical structure depicting the molecular formula of Tamsulosin Hydrochloride, showing its aromatic rings, functional groups, and hydrochloride component as indicated by the HCl notation.*
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 HCl Usp 2)

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 HCl Usp 2)
A line graph showing mean plasma concentrations of Tamsulosin Hydrochloride over time (up to 36 hours) after a single 0.4 mg capsule dose under fasted and fed conditions. The y-axis represents plasma concentration in ng/mL, and the x-axis represents time in hours. The graph includes separate curves for fasted and fed states, illustrating their concentration-time profiles.*
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Figure 2a Mean Change From Baseline In Total Aua Symptom Score (0 To 35) Study 1 (Tamsulosin HCl Usp 3)

Figure 2a Mean Change From Baseline In Total Aua Symptom Score (0 To 35) Study 1 (Tamsulosin HCl Usp 3)
A line graph depicting mean change from baseline in total AUA symptom score over time (weeks) during Study 1. The graph compares three treatments: 0.8 mg, 0.4 mg, and placebo, showing symptom score changes from 0 to 13 weeks and LOCF data. Mean change values decrease more for 0.8 mg and 0.4 mg compared to placebo.*
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Figure 2b Mean Change From Baseline In Total Aua Symptom Score (0 To 35) Study 2 (Tamsulosin HCl Usp 4)

Figure 2b Mean Change From Baseline In Total Aua Symptom Score (0 To 35) Study 2 (Tamsulosin HCl Usp 4)
A line graph depicting mean change from baseline in total AUA symptom score over 13 weeks for a clinical study. The x-axis shows treatment duration in weeks, and the y-axis shows mean change. Three treatment groups are shown: 0.8 mg dose (circle markers), 0.4 mg dose (triangle markers), and placebo (square markers). The graph illustrates symptom score changes decreasing over time for all groups, with the active doses showing greater reductions than placebo by week 13.*
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Figure 3a Mean Increase In Peak Urine Flow Rate (ml/sec) Study 1 (Tamsulosin HCl Usp 5)

Figure 3a Mean Increase In Peak Urine Flow Rate (ml/sec) Study 1 (Tamsulosin HCl Usp 5)
A line graph titled 'Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 1' showing mean change in peak urine flow rate over duration of treatment in weeks. Three treatment groups are compared: 0.8 mg, 0.4 mg, and placebo, with data points shown for baseline, several weeks, and last observation carried forward (LOCF). The graph illustrates trends of mean increases for each group across treatment duration.*
FDA Label Image

Figure 3b Mean Increase In Peak Urine Flow Rate (ml/sec) Study 2 (Tamsulosin HCl Usp 6)

Figure 3b Mean Increase In Peak Urine Flow Rate (ml/sec) Study 2 (Tamsulosin HCl Usp 6)
A line graph titled 'Figure 3B Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 2' showing mean change in urine flow rate over treatment duration in weeks. The graph compares three groups: 0.8 mg, 0.4 mg, and placebo, with mean change on the y-axis (mL/sec) and duration of treatment on the x-axis (0 to 13 weeks plus LOCF). The 0.8 mg and 0.4 mg treatments show higher mean increases than placebo over time.*
FDA Label Image

Image Description (Tamsulosin HCl Usp 7)

Image Description (Tamsulosin HCl Usp 7)
Tamsulosin Hydrochloride USP 0.4 mg capsule bottle label by Aidarex Pharmaceuticals LLC. The label states 30 capsules per container in green and orange oval oblong capsules with imprint 'D 53' on one side. It includes generic reference to Flomax and distributor information for Citron Pharma LLC, East Brunswick, NJ. NDC 53217-0154-30 is visible along with lot and RX numbers.*

* 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.