Sildenafil
Product Images NDC 50436-9121

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 50436-9121). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Label Image (Lbl504369121)

Sildenafil 20 mg tablet label with a quantity of 108 tablets. The label states each film-coated tablet contains Sildenafil Citrate equivalent to 20 mg of sildenafil. Manufactured by Macleods Pharm Ltd in Himachal Pradesh, India. Includes NDC 50436-9121-2 and instructions to keep out of reach of children with storage temperature guidance. Packaged by Unit Dose Services, LLC Davis, FL 33004. The label is marked RX ONLY and includes barcodes and a QR code.*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot chart depicting placebo-corrected changes in 6-minute walk distance (m) for Sildenafil 20 mg TID versus placebo. It compares subgroups based on baseline walk distance, etiology of pulmonary arterial hypertension, PH criteria for functional capacity, gender, age, mean pulmonary arterial pressure, and pulmonary vascular resistance index, showing effect sizes with confidence intervals.*

FDA Label Image

Figure-11 (Sildenafil Fig 11)

A line graph showing the percentage of subjects without a clinically worsening event over a period of 112 days from randomization. Two groups are compared: Placebo and Sildenafil, with the percentage tracked on the vertical axis and days on the horizontal axis.*

FDA Label Image

Fig-12 (Sildenafil Fig 12)

A line chart depicting the mean change from baseline (in meters) over 12 weeks of study for Sildenafil at 1 mg, 5 mg, and 20 mg doses taken three times daily (TID). The chart includes standard error bars for each data point at weeks 4, 8, and 12, illustrating treatment effects over time.*

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A Kaplan-Meier survival curve graph showing estimated cumulative mortality rates over time in years for three dose groups labeled High dose, Medium dose, and Low dose. The vertical axis represents the mortality rate percentage, and the horizontal axis shows time in years, with number of subjects at risk indicated above the graph.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A forest plot chart showing fold change and 90% confidence intervals for various interacting drugs (Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin at three doses, Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, Tolbutamide) relative to sildenafil alone. The vertical reference line at 1 indicates no change. Recommendations for dose adjustments accompany each drug, mostly indicating no dose adjustment except Ritonavir where coadministration is not recommended and Bosentan where no benefit on exercise capacity was noted.*

FDA Label Image

Figure-9 (Sildenafil Fig 9)

A line chart showing the change from baseline in meters over a 12-week study period. The x-axis represents the weeks of study (Week 4, Week 8, Week 12) and the y-axis shows the change from baseline in meters. The chart compares four groups: Placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID, using different markers for each group. The data points include error bars indicating variability.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A dot plot chart showing fold changes with 90% confidence intervals for various interacting drugs relative to sildenafil alone. The chart compares AUC and Cmax values for drugs such as Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. The right side includes dosing recommendations, mostly indicating no dose adjustment except for Ritonavir. The vertical line at x=1 represents no change relative to sildenafil alone.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure diagram of Sildenafil, displaying its molecular framework including rings, functional groups, and side chains as depicted in the image.*

* 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.