Sildenafil Tablet, Film Coated
Product Images NDC 68001-597

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 68001-597). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bluepoint Laboratories, 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

Image 01

Sildenafil Tablets 20 mg film-coated tablets label showing dosage strength and directions for storage. The label states the product contains sildenafil citrate equivalent to 20 mg sildenafil and includes instructions to dispense with patient information. Manufactured for BluePoint Laboratories with 90 tablets in the container, storage temperatures, and manufacturer details from Macleods Pharmaceuticals Ltd., India, are also listed.*

FDA Label Image

Sildenafil Label 20mg 90ct_rev 06-18 (Sildenafil 90s)

Label for Sildenafil Tablets, USP 20 mg film-coated tablets by BluePoint Laboratories. The label includes the NDC number 68001-363-05 and states the product contains sildenafil citrate equivalent to 20 mg sildenafil. It specifies storage instructions and manufacturer details, indicating production by Macleods Pharmaceuticals Ltd., India. The package count is 90 tablets.*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot chart comparing Sildenafil 20 mg taken three times daily versus placebo across various subgroups. The chart displays placebo-corrected changes in 6-minute walk distance (in meters) for groups categorized by baseline walk distance, PAH etiology, functional class, gender, age, mean PAP, and PVRI. Each subgroup has point estimates with confidence intervals illustrating the treatment effect.*

FDA Label Image

Figure-11 (Sildenafil Fig 11)

A Kaplan-Meier survival curve chart showing the percentage of patients without a clinically worsening event over days from randomization, comparing Sildenafil and placebo groups over a 112-day period.*

FDA Label Image

Figure 12 (Sildenafil Fig 12)

A line plot depicting mean change from baseline in meters on the y-axis over weeks of study (4, 8, 12) on the x-axis for Sildenafil at 1 mg, 5 mg, and 20 mg TID doses. Error bars indicate standard error for each treatment and visit, showing increasing change from baseline over time for all doses.*

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A line graph depicting estimated cumulative mortality rates over time in years for three dosage groups labeled High dose, Medium dose, and Low dose. The x-axis represents time in years, and the y-axis shows cumulative mortality rate percentages. The number of subjects at risk decreases over time across all dose groups, with the High dose group showing the highest cumulative mortality, followed by Medium and then Low dose groups.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A horizontal dot plot showing fold changes with 90% confidence intervals for various drugs interacting with sildenafil, indicating their impact on pharmacokinetic parameters like AUC, Cmax, and bleeding time. The chart also includes dosage adjustment recommendations for each interacting drug, mostly indicating no dose adjustment except for ritonavir, which advises against coadministration.*

FDA Label Image

Figure 9 (Sildenafil Fig 9)

A line chart depicting the change from baseline in meters over a 12-week study period, with data points at weeks 4, 8, and 12. The chart compares four groups: placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID, shown with distinct markers and error bars for variability.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A forest plot chart showing the fold change and 90% confidence intervals for the area under the curve (AUC) and maximum concentration (Cmax) of sildenafil when coadministered with various interacting drugs. The chart includes recommendations on dose adjustments, mostly indicating no dose adjustment except for ritonavir, which is not recommended for coadministration.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure diagram of Sildenafil, showing its molecular components and arrangement as presented in the product data.*

* 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.