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

10 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

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

Chemical Structure (Oxybutynin 1)

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)

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)

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)

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)

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)

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.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Bottle Label 5 mg (43353 0282 80)

Bottle Label 5 mg (43353 0282 80)
Label for Oxybutynin Chloride Extended Release 5 mg oral tablets, containing 180 tablets. The label includes storage instructions, safety warnings about child access and driving, manufacturer details (Kremers Urban Pharmaceuticals, Princeton, NJ, and Aphena Pharma, Cookeville, TN), and regulatory information including NDC 43353-0282-80 and a barcode.*
FDA Label Image

Bottle Label 10 mg (43353 0284 30)

Bottle Label 10 mg (43353 0284 30)
Oxybutynin Chloride ER 10 mg extended-release tablets, packaged as 30 tablets. The label includes storage instructions, NDC number 43353-0284-30, and indicates the manufacturer as Aphena Pharma Solutions - Tennessee, LLC located in Knoxville, TN. The label also specifies prescription use only (RX Only).*
FDA Label Image

Bottle Label 15 mg (43353 0322 16)

Bottle Label 15 mg (43353 0322 16)
Oxybutynin Chloride Extended Release (ER) 15 mg oral tablets packaging label showing a count of 6000 tablets. The label includes the NDC number 43353-0322-16, storage instructions between 20-25 degrees Celsius, dispensing information, and a warning to keep out of reach of children. The manufacturer is listed as Premier Urban Pharmaceuticals Inc., with the package by Aphena Pharma, Cookeville, TN 38506. The label indicates the product is prescription only.*

* 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.