Oxybutynin Chloride Tablet, Extended Release
Product Images NDC 16729-318

9 FDA label images from Accord Healthcare, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Oxybutynin Chloride (NDC 16729-318). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare, 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

Figure 1 (Oxybutynin Fig 1)

Figure 1 (Oxybutynin Fig 1)
A line graph showing mean plasma R-oxybutynin concentration (ng/mL) over 24 hours comparing oxybutynin extended-release (ER) 10 mg once daily (QD) and oxybutynin 5 mg three times daily (TID). The x-axis represents time in hours, and the y-axis shows concentration levels. Error bars indicate variability at each time point.*
FDA Label Image

Figure 2 (Oxybutynin Fig 2)

Figure 2 (Oxybutynin Fig 2)
A line graph showing mean R-oxybutynin plasma concentration (ng/mL) over time (hours), with data points at multiple intervals up to 24 hours displaying a relatively stable concentration around 0.5 to 0.7 ng/mL and error bars indicating variability at each time point.*
FDA Label Image

Figure 3 (Oxybutynin Fig Study 1)

Figure 3 (Oxybutynin Fig Study 1)
A horizontal mean change graph showing episodes per week from baseline comparing oxybutynin extended-release (ER) and placebo. The graph features a scale from -40 to 40, with oxybutynin ER indicating a negative mean change and placebo spanning a range closer to zero. Standard deviation bars are included for both.*
FDA Label Image

Figure 4 (Oxybutynin Fig Study 2)

Figure 4 (Oxybutynin Fig Study 2)
A horizontal bar chart comparing the mean change (± SD) in episodes per week from baseline between oxybutynin ER and oxybutynin. The x-axis represents the mean change in episodes per week, ranging from -40 to 40, with baseline at 0. Mean changes for both oxybutynin ER and oxybutynin are shown with error bars.*
FDA Label Image

Figure 5 (Oxybutynin Fig Study 3)

Figure 5 (Oxybutynin Fig Study 3)
A horizontal bar chart depicting the mean change (±SD) in episodes per week from baseline. The chart compares oxybutynin extended release (ER) and oxybutynin, showing reductions in episodes over a range from approximately -40 to 40 on the horizontal axis.*
FDA Label Image

Figure 8 (Oxybutynin Lab 10mg)

Figure 8 (Oxybutynin Lab 10mg)
Label for oxybutynin chloride extended-release tablets, USP, 10 mg strength, manufactured by Intas Pharmaceuticals Limited and labeled by Accord Healthcare, Inc. The label indicates a 30-tablet package with oral route and prescription only status. Storage instructions recommend 25°C with permitted excursions up to 30°C. The label includes multiple barcodes and regulatory compliance information.*
FDA Label Image

Figure 9 (Oxybutynin Lab 15mg)

Figure 9 (Oxybutynin Lab 15mg)
Label for Oxybutynin Chloride Extended-release Tablets, USP 15 mg, oral tablets by Accord Healthcare, Inc. The package contains 30 tablets and is Rx only. Storage and excipient information along with manufacturer details (Intas Pharmaceuticals Limited, India) are also included. The label features NDC 16729-319-10 and barcode.*
FDA Label Image

Figure 7 (Oxybutynin Lab 5mg)

Figure 7 (Oxybutynin Lab 5mg)
Label for oxybutynin chloride extended-release tablets, USP, 5 mg strength. The label states 30 tablets per package, prescription use only, and includes storage instructions. Manufactured by Intas Pharmaceuticals Limited and labeled by Accord Healthcare, Inc. The label also displays NDC 16729-317-10 and features barcodes and handling instructions.*
FDA Label Image

Chemical Structure (Oxybutynin Struc)

Chemical Structure (Oxybutynin Struc)
Chemical structure diagram of oxybutynin chloride, showing the molecular arrangement including aromatic ring, ester linkage, and hydrochloride salt form.*

* 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.