Gemtesa Tablet, Film Coated
Product Images NDC 73336-075

4 FDA label images from Sumitomo Pharma America, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Gemtesa (NDC 73336-075). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sumitomo Pharma America, 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

Chemical Structure (Gemtesa 01)

Chemical Structure (Gemtesa 01)
Chemical structure diagram of vibegron, the active ingredient in GEMTESA 75 mg oral tablets by Sumitomo Pharma America, Inc.*
FDA Label Image

Figure 1 (Gemtesa 02)

Figure 1 (Gemtesa 02)
A line chart comparing change from baseline over 12 weeks between GEMTESA 75 mg and placebo groups. The x-axis shows weeks (Baseline, 2, 4, 8, 12) and the y-axis shows LS Mean (SE) change from baseline, ranging approximately from 0 to -2.25. The GEMTESA 75 mg group is represented by a solid line with diamond markers, showing a steeper decline compared to the placebo group, which is shown as a dashed line with circle markers. Both groups demonstrate decreasing values over time, with the GEMTESA group consistently lower than placebo.*
FDA Label Image

Figure 2 (Gemtesa 03)

Figure 2 (Gemtesa 03)
A line graph comparing the LS Mean (SE) change from baseline over time between GEMTESA 75 mg and placebo groups. The x-axis shows weeks (Baseline, 2, 4, 8, 12), and the y-axis shows change from baseline values. GEMTESA 75 mg data is represented by a solid line with diamond markers, while placebo is a dashed line with circle markers, illustrating greater change with GEMTESA over the 12-week period.*
FDA Label Image

Principal Display Panel (75 mg Tablet Bottle Label)

Principal Display Panel (75 mg Tablet Bottle Label)
GEMTESA 75 mg (vibegron) film coated tablets label showing a 30-tablet bottle. Label includes dosage form and strength, Rx only designation, instructions for use, storage conditions, barcode, lot and expiration info, manufacturer name (Urovant Sciences, Inc.), and patient resource contact details.*

* 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.