Sildenafil Tablet, Film Coated
Product Images NDC 68071-4517

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 68071-4517). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare Pharmaceuticals,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

68071 4517 9

Label for Sildenafil 20 mg tablets, film-coated, prescription drug by NuCare Pharmaceuticals, Inc. The label indicates a package size of 90 tablets. It includes NDC 68071-4517-9 and manufacturing details with storage instructions to keep at controlled temperatures between 59-86°F. The label also advises keeping the product out of reach of children and refers to the manufacturer's label for a full list of ingredients.*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot showing placebo-corrected change in 6-minute walk distance (meters) in patients treated with Sildenafil 20 mg three times daily. The plot compares subgroups based on baseline walk distance, etiology, PH functional class, gender, age, mean pulmonary artery pressure, and pulmonary vascular resistance index, with confidence intervals for each subgroup's change in walking distance.*

FDA Label Image

Figure-11 (Sildenafil Fig 11)

A line graph showing the percentage of subjects without a clinically worsening event over time, measured in days from randomization, comparing Sildenafil and Placebo groups. The y-axis represents the percentage without worsening events, and the x-axis shows days from 0 to 112. The graph includes a legend identifying lines for Placebo and Sildenafil.*

FDA Label Image

Fig-12 (Sildenafil Fig 12)

A line graph showing the mean change from baseline in meters over 12 weeks of study for three Sildenafil dosages: 1 mg TID, 5 mg TID, and 20 mg TID. The vertical axis represents change from baseline in meters, while the horizontal axis shows weeks 4, 8, and 12. Data points include standard error bars for each treatment at each visit.*

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A line graph depicting estimated cumulative mortality rate (%) over time (years) for three dosing groups labeled high dose, medium dose, and low dose. The graph includes a risk table showing the number of subjects at risk for each group at various time points up to 5 years. Mortality rates increase over time, with high dose showing the highest rate, followed by medium dose, and low dose the lowest.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A forest plot chart showing fold change and 90% confidence intervals in various pharmacokinetic parameters (including INR AUC, INR Cmax, and bleeding time) for interacting drugs combined with sildenafil. The chart lists drugs such as Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin (1, 2, 3), Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide, along with dosing recommendations. Recommendations indicate mostly no dose adjustments needed, except Ritonavir which advises that coadministration is not recommended. Error bars illustrate changes relative to each interacting drug alone.*

FDA Label Image

Figure-9 (Sildenafil Fig 9)

A line graph showing the change from baseline in meters over 4, 8, and 12 weeks of study for Sildenafil at 20 mg, 40 mg, and 80 mg TID doses compared to placebo. The y-axis represents change from baseline in meters, and the x-axis represents the week of study. Error bars indicate variability for each data point.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A chart showing the fold change and 90% confidence interval of pharmacokinetic parameters AUC and Cmax for Sildenafil when coadministered with various interacting drugs. The x-axis represents change relative to Sildenafil alone, and the chart includes recommendations on dose adjustment for each drug interaction.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure diagram of Sildenafil, the active ingredient in the described product. The diagram shows the molecular components and connectivity specific to Sildenafil's chemical formula.*

* 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.