Sildenafil Tablet, Film Coated
Product Images NDC 76420-061

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 76420-061). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Asclemed Usa, 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

20mg-30s (Sildenafil 20mg 30s)

Sildenafil Tablets USP 20 mg film-coated tablets in a 30-count package. The label shows packaging by Enovachem Pharmaceuticals and manufacturing by Macleods Pharma USA, Inc. It includes product NDC 76420-061-30 and cautions about federal law restricting dispensing without prescription. The tablets are white to off-white, round, and film-coated.*

FDA Label Image

20mg-90's (Sildenafil 20mg 90s)

Sildenafil Tablets USP 20 mg packaging label from Enovachem Pharmaceuticals. The label shows a NDC code of 76420-061-90, a quantity of 90 tablets, and indicates the product is film-coated, off-white, and round. Labeler address is in Torrance, CA, with manufacturing for Macleods Pharma USA, Inc. Additional details include lot, expiration date, and storage instructions.*

FDA Label Image

Figure-10 (Sildenafil Fig 10)

A forest plot chart depicting placebo-corrected changes in 6-minute walk distance (meters) for Sildenafil 20 mg taken three times daily. The chart compares subgroups by baseline walk distance, etiology, pulmonary hypertension criteria, 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 comparing the percentage without a clinically worsening event over days from randomization between two groups labeled Placebo and Sildenafil. The x-axis represents days from randomization, ranging from 0 to 112, and the y-axis shows the percentage without a clinically worsening event, ranging from 0 to 100.*

FDA Label Image

Fig-12 (Sildenafil Fig 12)

A line graph showing the mean change from baseline in meters for Sildenafil doses 1 mg, 5 mg, and 20 mg taken three times daily (TID) over 12 weeks. The x-axis represents the weeks of study (Week 4, Week 8, Week 12), and the y-axis represents the change from baseline in meters with error bars indicating standard error for each treatment at each visit.*

FDA Label Image

Fig-6 (Sildenafil Fig 6)

A line graph showing estimated cumulative mortality rate (%) over time in years for three different dosage groups labeled High dose, Medium dose, and Low dose. The graph includes numbers at risk for each group at various time points up to 5 years.*

FDA Label Image

Fig-8 (Sildenafil Fig 8)

A chart titled 'Fold Change and 90% CI' illustrating the effect of various interacting drugs on the pharmacokinetics of sildenafil. The horizontal axis shows the fold change relative to the interacting drug alone, with a vertical reference line at 1. Different drugs are listed on the left, with markers indicating changes in parameters such as AUC, Cmax, INR, and BT. Recommendations regarding dose adjustments are provided on the right, mostly indicating no dose adjustment, with exceptions for ritonavir (coadministration not recommended) and a note on bosentan therapy.*

FDA Label Image

Figure-9 (Sildenafil Fig 9)

A line graph showing change from baseline in meters on the vertical axis over study weeks 4, 8, and 12 on the horizontal axis. It compares four groups: Placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID, each represented with distinct markers. Error bars indicate variability for each data point.*

FDA Label Image

Figure-7 (Sildenafil Figure 7)

A forest plot chart illustrating the fold change and 90% confidence intervals for the pharmacokinetic parameters AUC and Cmax of Sildenafil when coadministered with various interacting drugs. The x-axis shows the fold change relative to Sildenafil alone, with a reference vertical line at 1. The chart includes drugs such as Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral contraceptives, Ritonavir, and Saquinavir, along with dosage adjustment recommendations for each interaction.*

FDA Label Image

Str (Sildenafil Str)

Chemical structure diagram of sildenafil, showing its molecular connectivity including characteristic functional groups such as a pyrazolo[4,3-d]pyrimidinone core, sulfonamide moiety, and piperazine ring. The structure also includes a citrate moiety indicating sildenafil citrate form.*

* 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.