Gemtesa Tablet, Film Coated
Product Images NDC 73336-075

10 FDA label images from Sumitomo Pharma America, Inc. · 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 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

Structural Formula Of Vibegron (Gem0l 0004 01)

Structural Formula Of Vibegron (Gem0l 0004 01)
Chemical structure diagram of vibegron, the active ingredient in GEMTESA. The diagram shows the molecular composition with labeled atoms and bonds characteristic of the compound.*
FDA Label Image

Figure 1 (Gem0l 0004 02)

Figure 1 (Gem0l 0004 02)
A line graph comparing the change in LS Mean of Diurnal Number of Urinations over 12 weeks between GEMTESA 75 mg and placebo groups. The x-axis represents time in weeks (Baseline, 2, 4, 8, 12), and the y-axis shows the LS Mean Diurnal Number of Urinations difference from baseline. The GEMTESA group exhibits a greater decrease in urinations compared to placebo across the study period.*
FDA Label Image

Figure 2 (Gem0l 0004 03)

Figure 2 (Gem0l 0004 03)
A line graph comparing the mean change from baseline over 12 weeks between two treatment groups: GEMTESA 75 mg and placebo. The x-axis represents time in weeks (0, 4, 8, 12), and the y-axis shows the 1.0 log10 change from baseline values, with error bars indicating variability in measurements.*
FDA Label Image

Figure 3 (Gem0l 0004 04)

Figure 3 (Gem0l 0004 04)
A line graph comparing the least squares mean change from baseline across 24 weeks for GEMTESA 75 mg and placebo groups. The x-axis shows weeks from baseline to 24, and the y-axis represents change values. GEMTESA shows a greater reduction trend compared to placebo over time, with standard error bars for each point.*
FDA Label Image

Figure 4 (Gem0l 0004 05)

Figure 4 (Gem0l 0004 05)
A line graph comparing the LS mean change from baseline over 24 weeks for GEMTESA 75 mg film-coated tablets versus placebo. The x-axis represents weeks from baseline to 24, and the y-axis shows the LS mean change. The graph includes two lines, one for GEMTESA 75 mg and one for placebo, with data points and error bars indicating standard error.*
FDA Label Image

Logo (Gem0l 0004 06)

Logo (Gem0l 0004 06)
GEMTESA 75 mg film-coated tablets packaging, labeled with the active ingredient vibegron. The box displays the manufacturer as Sumitomo Pharma America, Inc. The packaging is primarily white with purple and grey accents, featuring the product name prominently on the front. The label indicates it is an oral prescription drug.*
FDA Label Image

Logo (Gem0l 0004 07)

Logo (Gem0l 0004 07)
The image shows a white film-coated tablet identified as GEMTESA 75 mg by Sumitomo Pharma America, Inc. The tablet is round and plain with no visible markings or scoring on the film coating surface.*
FDA Label Image

Logo (Gem0l 0004 08)

Logo (Gem0l 0004 08)
GEMTESA 75 mg film-coated oral tablets packaging featuring the brand name prominently in blue with '75 mg TABLET' and the active ingredient vibegron indicated. The package design incorporates a green and blue color scheme with a white background. The labeler is Sumitomo Pharma America, Inc., and the front of the carton is shown including a partial view of the package size and NDC information.*
FDA Label Image

Logo (Gem0l 0004 09)

Logo (Gem0l 0004 09)
GEMTESA 75 mg film-coated tablet packaging, labelled with the Sumitomo Pharma America, Inc. logo. The rectangular carton appears white with black text and features the proprietary name GEMTESA and the dosage strength of 75 mg prominently.*
FDA Label Image

Principal Display Panel (75 mg Tablet Bottle Label)

Principal Display Panel (75 mg Tablet Bottle Label)
Label for GEMTESA (vibegron) 75 mg film-coated tablets, for oral use. The carton contains 30 tablets, labeled for prescription use only. The label includes the NDC 73336-075-30, manufacturer Sumitomo Pharma America, Inc., storage instructions at 20°C to 25°C, and dosage guidance of one tablet once daily. Additional information advises reading full prescribing information and keeping the medication out of children's reach.*

* 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.