Oxybutynin Chloride Tablet, Extended Release
Product Images NDC 43353-282

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Oxybutynin Chloride (NDC 43353-282). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Bottle Label 5 mg (43353 282 30)

Label for Oxybutynin Chloride ER 5 mg extended release oral tablets, containing 30 tablets per package. The label includes storage instructions, manufacturer information (Kemrex, Litha Pharmaceuticals Inc., Princeton, NJ), and repackaging details by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. It also displays NDC numbers and a barcode, with an RX Only designation.*

FDA Label Image

Bottle Label 10 mg (43353 284 30)

Label for Oxybutynin Chloride Extended Release (ER) 10 mg tablets. The label indicates a package size of 30 oral extended-release tablets. It includes dosage strength, usage instructions mentioning controlled release, storage and safety warnings, and the labelers Kremers Urban Pharmaceuticals Inc., Princeton, NJ, and repackager Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN.*

FDA Label Image

Bottle Label 15 mg (43353 322 16)

Label for Oxybutynin Chloride Extended Release 15 mg oral tablets, 6000 count. The label includes the NDC number 43353-0322-16 and storage instructions to keep between 20-25 degrees Celsius. Manufactured by Kremers Urban Pharmaceuticals Inc., repackaged by Aphena Pharma Solutions - Tennessee, LLC.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Chemical Structure (Oxybutynin 1)

Chemical structure of Oxybutynin Chloride showing its molecular components including aromatic rings, ester linkage, alkyne group, and hydrochloride salt.*

FDA Label Image

Figure 1 (Oxybutynin 2)

A line graph showing mean plasma oxybutynin concentration (ng/mL) over 24 hours. Two lines compare oxybutynin chloride extended-release tablets with oxybutynin 5 mg taken three times daily (TID), illustrating differences in plasma concentration profiles across time.*

FDA Label Image

Figure 2 (Oxybutynin 3)

A line graph depicting the mean plasma concentration of R-Oxybutynin (ng/mL) over a 24-hour period. The x-axis represents time in hours, ranging from 0 to 24, while the y-axis shows concentration values from 0.0 to 2.0 ng/mL. Data points include error bars indicating variability at each time interval.*

FDA Label Image

Figure 2 (Oxybutynin 4)

A horizontal error bar chart comparing mean change in episodes per week from baseline between oxybutynin chloride extended-release tablets and placebo, displaying mean change with standard deviation bars along a scale from -40 to 40.*

FDA Label Image

Figure 3 (Oxybutynin 5)

A horizontal bar chart depicting the mean change with standard deviation in episodes per week from baseline for oxybutynin chloride extended-release tablets. The chart shows a negative mean change for oxybutynin, indicating a decrease in episodes per week compared to baseline, with a scale ranging approximately from -40 to 40 episodes.*

FDA Label Image

Figure 4 (Oxybutynin 6)

A line chart showing mean change (±SD) in episodes per week from baseline for oxybutynin chloride extended-release tablets. The x-axis represents the change in episodes, ranging from -40 to 40. The graph compares oxybutynin to placebo, indicating their respective effects over time.*

* 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.