Sildenafil Citrate Tablet
Product Images NDC 80425-0304

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Sildenafil Citrate (NDC 80425-0304). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Rx Pharmacy Of Tennessee, Llc, 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

Description (Description)

Description (Description)
Chemical structure diagram of Sildenafil Citrate, showing the molecular arrangement including rings, nitrogen atoms, and functional groups as part of the compound's chemical composition.*
FDA Label Image

Fig 1 (Fig 1)

Fig 1 (Fig 1)
A scatter plot with error bars showing fold change and 90% confidence intervals for AUC and Cmax values of sildenafil citrate when coadministered with various interacting drugs. The vertical line at 1 indicates the baseline effect of sildenafil alone. Recommendations for dose adjustment or coadministration are listed for each drug.*
FDA Label Image

Label 1 (Sildenafil Citrate 20mg 80425 0304 01)

Label 1 (Sildenafil Citrate 20mg 80425 0304 01)
Sildenafil Citrate 20 mg tablet packaging label from Advanced Rx Pharmacy of Tennessee, LLC. The label includes storage instructions (20°-25°C), a comparison to Revatio, lot number and expiration date (5/31/2024), and a quantity of 30 tablets. The product NDC is 80425-0304-01. The label features a barcode and a QR code.*
FDA Label Image

Label 2 (Sildenafil Citrate 20mg 80425 0304 02)

Label 2 (Sildenafil Citrate 20mg 80425 0304 02)
Sildenafil Citrate 20 mg tablet packaging label includes patient information, storage instructions (20-25°C), and lot expiry date of 5/31/2024. The label shows the product NDC 80425-0304 and references comparison to Revatio with source NDC 13668-0185-90. It also lists Advanced Rx Pharmacy of Tennessee, LLC, and Torrent Pharma as associated entities.*
FDA Label Image

Label 3 (Sildenafil Citrate 20mg 80425 0304 03)

Label 3 (Sildenafil Citrate 20mg 80425 0304 03)
Sildenafil Citrate 20 mg tablet label from AdvancedRx Pharmacy of Tennessee, LLC. The label includes storage instructions (20-25°C), a comparison to Revatio, NDC numbers, lot number, expiration date (5/31/2024), and additional label information including a QR code and pharmacy details.*
FDA Label Image

Fig 2 (Fig 2)

Fig 2 (Fig 2)
A forest plot chart showing fold change and 90% confidence intervals for various interacting drugs with Sildenafil Citrate. The chart compares pharmacokinetic parameters (AUC, Cmax, INR AUC, INR Cmax, bleeding time) relative to each interacting drug alone, with recommendations on dose adjustments or coadministration. Drugs listed include Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin (three doses), Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide.*
FDA Label Image

Fig 3 (Fig 3)

Fig 3 (Fig 3)
A line graph displaying changes from baseline in meters over a 12-week study period at weeks 4, 8, and 12. The graph compares placebo and three Sildenafil dosages (20 mg TID, 40 mg TID, 80 mg TID), showing increasing effects over time with error bars indicating variability.*
FDA Label Image

Fig 4 (Fig 4)

Fig 4 (Fig 4)
A forest plot chart depicting placebo-corrected changes in 6-minute walk distance in meters for Sildenafil Citrate 20 mg taken three times daily. The chart compares multiple subgroups based on baseline walk distance, etiology, pulmonary hypertension criteria, gender, age, mean PAP, and PVRI, showing point estimates with confidence intervals for each subgroup.*
FDA Label Image

Fig 5 (Fig 5)

Fig 5 (Fig 5)
A line graph showing the percentage without a clinically worsening event over time (days from randomization) comparing Sildenafil and Placebo groups. The y-axis represents the percentage without event, and the x-axis represents days from randomization up to 112 days. Two lines are shown: a dashed line for Sildenafil and a solid line for Placebo, indicating relative event-free percentages over time.*
FDA Label Image

Fig 6 (Fig 6)

Fig 6 (Fig 6)
A bar graph depicting the percentage change in VO2 peak across different treatment groups: Placebo, Low Dose, Medium Dose, High Dose, and Combined Doses. Each group includes sample sizes (n=24 to 77). The graph shows the mean change with error bars indicating variability for Sildenafil Citrate dosing groups compared to placebo.*
FDA Label Image
FDA Label Image

Table 6 (Table 6)

Table 6 (Table 6)
A data table titled 'Hazard Ratios for Overall Survival, Assessed in the Proportional Hazards Model – Intent To Treat Population.' It compares survival data across three Sildenafil dosages (5 mg, 20 mg, and 80 mg) including patient-years of follow-up, number of deaths on and off treatment, hazard ratio estimates, and 99.7% confidence intervals, with footnotes explaining on-treatment deaths and hazard ratio calculations.*
FDA Label Image

Table 7 (Table 7)

Table 7 (Table 7)
A data table titled 'Hazard Ratios for Time to First Event of Clinical Worsening – Intent To Treat Population' comparing clinical worsening event counts and hazard ratios for Sildenafil doses 5 mg, 20 mg, and 80 mg. The table includes patient-years of follow-up, number of patients with clinical worsening, and detailed first events such as disease progression, hospitalization for PAH, and death. Hazard ratio estimates with confidence intervals and p-values are also presented.*

* 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.