Trospium Chloride Tablet, Film Coated
Product Images NDC 69097-912

7 FDA label images from Cipla Usa 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 Trospium Chloride (NDC 69097-912). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cipla Usa 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

20mg (20mg)

20mg (20mg)
Label for Trospium Chloride tablets, USP 20 mg film-coated oral tablets. The label indicates a supply of 60 tablets manufactured for Cipla USA Inc. It includes storage instructions at 20° to 25°C and directs pharmacists to dispense with patient information leaflets. The label features the Cipla logo, a barcode, and product NDC 69097-912-03.*
FDA Label Image

Trospium Chloride Structural Formula (Image 01)

Trospium Chloride Structural Formula (Image 01)
Chemical structure diagram of Trospium Chloride showing its molecular arrangement, including the tropanium cation, chloride anion, and associated aromatic and bicyclic structures.*
FDA Label Image

Figure 1 -mean (+ Sd) Concentration-time Profile For A Single 20 mg Oral Dose Of Trospium Chloride Tablets In Healthy Volunteers (Image 02)

Figure 1 -mean (+ Sd) Concentration-time Profile For A Single 20 mg Oral Dose Of Trospium Chloride Tablets In Healthy Volunteers (Image 02)
A line graph depicting plasma concentration (ng/mL) over time (hours post-dose) for Trospium Chloride 20 mg oral tablets. The graph shows plasma concentration peaking within the first 4 hours and declining gradually over 48 hours, with error bars indicating variability at each time point.*
FDA Label Image

Figure 2 – Mean Change From Baseline In Urinary Frequency/24 Hours, By Visit: Study 1 (Image 03)

Figure 2 – Mean Change From Baseline In Urinary Frequency/24 Hours, By Visit: Study 1 (Image 03)
A line graph comparing mean change over weeks of treatment between placebo (N=256) and Trospium chloride (N=253) groups. The x-axis shows treatment weeks (1, 4, and 12), and the y-axis displays mean change with standard error. Trospium chloride shows a greater decrease in mean values over time, with p-values indicating statistical significance at weeks 4 and 12.*
FDA Label Image

Figure 3 – Mean Change From Baseline In Urge Incontinence/week, By Visit: Study 1 (Image 04)

Figure 3 – Mean Change From Baseline In Urge Incontinence/week, By Visit: Study 1 (Image 04)
A line graph comparing mean (± SE) change over weeks 1, 4, and 12 of treatment for Trospium Chloride versus placebo in a clinical study. The x-axis represents the week of treatment, and the y-axis shows the mean change values. The graph includes p-values indicating statistical comparisons at each time point between the two groups.*
FDA Label Image

Figure 4 – Mean Change From Baseline In Urinary Frequency/24 Hours, By Visit: Study 2 (Image 05)

Figure 4 – Mean Change From Baseline In Urinary Frequency/24 Hours, By Visit: Study 2 (Image 05)
A line graph comparing the mean (± SE) change over weeks of treatment between placebo and Trospium chloride groups. The x-axis represents weeks of treatment (1, 4, 12) and the y-axis shows mean change values. The graph shows Trospium chloride with a greater reduction over time compared to placebo, with statistical significance indicated at each time point.*
FDA Label Image

Figure 5 – Mean Change From Baseline In Urge Incontinence/week, By Visit: Study 2 (Image 06)

Figure 5 – Mean Change From Baseline In Urge Incontinence/week, By Visit: Study 2 (Image 06)
A line graph comparing mean change (± standard error) over 12 weeks for two groups: Placebo (N=325) and Trospium Chloride (N=323). The x-axis represents weeks of treatment (1, 4, 12) and the y-axis shows mean change values, with Trospium Chloride consistently showing greater negative mean change than Placebo, with p-values less than 0.001 at all time points.*

* 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.