Fesoterodine Fumarate Tablet, Extended Release
Product Images NDC 65162-370

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This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Fesoterodine Fumarate (NDC 65162-370). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal 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

Structural Fomula (Fesoterodine Fumarate Extended Release Tablets 1)

FDA Label Image

Figure 1 (Fesoterodine Fumarate Extended Release Tablets 2)

Figure 1 (Fesoterodine Fumarate Extended Release Tablets 2)
The text describes a figure showing the change in the number of urinations per 24 hours in a study with three groups: a placebo group, a group taking fesoterodine fumarate 4mg, and a group taking fesoterodine fumarate 8mg. The figure tracks the change over a period of 12 weeks. The title of the figure is "Change in Number of Micturitions per 24 h (Study 1)". The description mentions "Mean change from baseline", but no values are provided.*
FDA Label Image

Figure 2 (Fesoterodine Fumarate Extended Release Tablets 3)

Figure 2 (Fesoterodine Fumarate Extended Release Tablets 3)
The text describes a graph that shows the change in urge incontinence episodes per 24 hours in a study which took place across 12 weeks. The graph displays three results: a placebo group of 211 individuals, a group of 199 individuals given Fesoterodine fumarate 4mg, and a group of 223 individuals given Fesoterodine fumarate 8mg. The text also provides a title for the graph and a measurement unit for the y-axis.*
FDA Label Image

Figure 3 (Fesoterodine Fumarate Extended Release Tablets 4)

Figure 3 (Fesoterodine Fumarate Extended Release Tablets 4)
This is a graph showing the mean change in the number of micturitions per 24 hours over a 12-week period for three groups: placebo (N=266), fesoterodine fumarate 4 mg (N=267), and fesoterodine fumarate 8 mg (N=267). The x-axis shows the weeks while the y-axis shows the change from baseline. No other information is available.*
FDA Label Image

Figure 4 (Fesoterodine Fumarate Extended Release Tablets 5)

Figure 4 (Fesoterodine Fumarate Extended Release Tablets 5)
The text describes a figure showing the change in urge incontinence episodes per 24 hours over a 12 week period in a study with three groups: a placebo group (N=205), a group taking fesoterodine fumarate 4 mg (N=228), and a group taking fesoterodine fumarate 8 mg (N=218). The x-axis shows the weeks and the y-axis shows the mean change from baseline in urge incontinence episodes per 24 hours.*
FDA Label Image

4 mg 30 Count Label (Fesoterodine Fumarate Extended Release Tablets 6)

4 mg 30 Count Label (Fesoterodine Fumarate Extended Release Tablets 6)
This text describes a medication with the NDC code 65162-369-03, which comes in the form of an extended-release film-coated tablet containing 4mg of fesoterodine fumarate. The usual dosage and storage instructions are provided alongside a request for pharmacists to dispense the medication with a patient information leaflet and protect it from moisture. The medication is distributed by Amneal Pharmaceuticals LLC.*
FDA Label Image

8 mg 30 Count Label (Fesoterodine Fumarate Extended Release Tablets 7)

8 mg 30 Count Label (Fesoterodine Fumarate Extended Release Tablets 7)
This is a medication with NDC number 65162-370-03. Each tablet of this medication is extended-release and film-coated containing 8mg of fesoterodine fumarate. The recommended dosage of this medication is available in the accompanying prescribing information. It is suggested to store the tablets at 20 to 25°C (68 to 77°F) with excursions permitted between 15 to 30°C (59 to 86°F). The medication should be protected from moisture. It is distributed by Amneal Pharmaceuticals LLC, located in Bridgewater, NJ. This information is current as of January 2021.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.