Tamsulosin Hydrochloride
Product Images NDC 68071-2197

7 FDA label images from Nucare Pharmaceuticals,inc. · 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 68071-2197). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare Pharmaceuticals,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

Pdp (68071 2197 03 A96)

Pdp (68071 2197 03 A96)
Tamsulosin Hydrochloride 0.4mg capsules label from NuCare Pharmaceuticals, Inc. The label indicates each capsule contains 0.4mg of Tamsulosin Hydrochloride USP. Capsules are described as oblong, olive green opaque/orange opaque with 'D' and '53' imprinted. The label includes NDC 68071-2197-3, lot number, expiration date placeholders, storage instructions, and warnings to keep out of reach of children.*
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 concentrations of Tamsulosin Hydrochloride over time after a single 0.4 mg dose, comparing fasted versus fed conditions. The x-axis represents time in hours (0 to 36), and the y-axis shows plasma concentration in ng/mL (0 to 25). Two curves illustrate concentration changes under fasting and fed states for eight subjects.*
FDA Label Image

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 the mean change from baseline in total AUA symptom score over treatment duration in weeks. Three treatment groups are shown: Tamsulosin Hydrochloride 0.8 mg, 0.4 mg, and placebo. The y-axis shows mean change, and the x-axis shows weeks of treatment plus baseline and LOCF (last observation carried forward). Both Tamsulosin groups show greater symptom improvement over time compared to placebo, with 0.8 mg leading to the largest decrease.*
FDA Label Image

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 illustrating the mean change from baseline in total AUA symptom score over a 13-week treatment period in Study 2. Three groups are compared: 0.8 mg (circle markers), 0.4 mg (triangle markers), and placebo (square markers). The x-axis represents duration of treatment in weeks, and the y-axis shows mean change in symptom score from 0 to -11.*
FDA Label Image

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 mean change in urine flow rate over treatment duration in weeks. Three treatments are compared: 0.8 mg dose (circle markers), 0.4 mg dose (triangle markers), and placebo (square markers). The graph depicts mean change values on the y-axis and weeks of treatment on the x-axis, with sample sizes noted at various time points.*
FDA Label Image

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 'Figure 3B Mean Increase in Peak Urine Flow Rate (mL/Sec) Study 2' showing mean change in mL/sec over 13 weeks of treatment plus last observation carried forward (LOCF). The graph compares three treatments: 0.8 mg, 0.4 mg, and placebo, with 0.4 mg showing the highest peak at week 1, followed by 0.8 mg, and placebo showing the lowest increase throughout.*
FDA Label Image

Chemical Structure (Tamsulosin Str)

Chemical Structure (Tamsulosin Str)
Chemical structure diagram of the active ingredient tamsulosin hydrochloride, showing its molecular composition and arrangement including aromatic rings, side chains, and substituents.*

* 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.