Sildenafil Tablet, Film Coated
Product Images NDC 33342-121

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 33342-121). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods Pharmaceuticals Limited, 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

Carton (Carton)

Sildenafil Tablets 20 mg film-coated oral tablets packaging label. The label indicates the product contains 100 tablets (10 x 10 unit dose tablets) and is manufactured by Macleods Pharmaceuticals Ltd, India, with distribution by Macleods Pharma USA, Inc. Additional information includes storage instructions and a note to dispense with the patient information leaflet.*

FDA Label Image

Foil (Foil)

Label set for Sildenafil 20 mg film-coated tablets from Macleods Pharmaceuticals Limited. Each label shows the product name, strength, manufacturer details indicating manufacturing in India, and a barcode. The layout is repetitive with consistent branding and information across multiple labels.*

FDA Label Image

Sildenafil 20mg 90s

Label for Sildenafil Tablets USP 20 mg, film-coated oral tablets by Macleods Pharmaceuticals Limited. The label indicates each tablet contains 20 mg sildenafil citrate, with storage instructions at controlled room temperature and dispensing information. The package includes 90 tablets and lists Macleods Pharma USA, Inc. as the manufacturer for the U.S. market, with manufacturing also noted in India.*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot showing placebo-corrected changes in 6-minute walk distance for Sildenafil 20 mg TID across subgroups based on baseline walk distance, etiology, PH criteria and therapeutic class, gender, age, mean PAP, and PVRI. Data points include sample sizes and confidence intervals for each subgroup.*

FDA Label Image

Figure-11 (Sildenafil Fig 11)

A Kaplan-Meier survival curve chart comparing the percentage of patients without a clinically worsening event over time (up to day 112) between sildenafil and placebo groups in a clinical study. The x-axis represents days from randomization, and the y-axis shows the percentage without worsening events. The graph includes a legend indicating placebo and sildenafil groups.*

FDA Label Image

Fig-12 (Sildenafil Fig 12)

A line graph showing the mean change from baseline in meters over 12 weeks for Sildenafil doses of 1 mg, 5 mg, and 20 mg taken three times daily (TID). The vertical axis measures change in meters, while the horizontal axis represents weeks of study at weeks 4, 8, and 12, with error bars indicating standard error for each data point.*

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A line graph showing estimated cumulative mortality rates over 5 years for three dose groups labeled High dose, Medium dose, and Low dose. The x-axis represents time in years, and the y-axis shows the mortality rate in percentage. A table above the graph lists the number of individuals at risk for each dose group and time point.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A forest plot chart titled "Interacting Drug" displays fold change and 90% confidence intervals comparing various drugs when combined with sildenafil. The vertical axis lists interacting drugs, with horizontal axis showing fold change relative to the interacting drug alone. Recommendations for dose adjustments are noted, mostly indicating no dose adjustment except for ritonavir, where coadministration is not recommended. The chart includes fold changes for parameters like INR, AUC, Cmax, and bleeding time for drugs such as Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin, Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide.*

FDA Label Image

Figure-9 (Sildenafil Fig 9)

A line graph showing change from baseline in meters on the vertical axis over weeks 4, 8, and 12 on the horizontal axis. The graph compares four groups: placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID, with markers representing data points and error bars indicating variability.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A chart depicting the fold change and 90% confidence intervals of area under the curve (AUC) and maximum concentration (Cmax) for various interacting drugs relative to Sildenafil alone. The graph includes data points for Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir with corresponding recommendations on dose adjustment.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure of Sildenafil is shown in the image, depicting its molecular formula components including rings and functional groups consistent with the active pharmaceutical ingredient Sildenafil.*

* 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.