Sildenafil Tablet, Film Coated
Product Images NDC 35561-251

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 35561-251). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bostal 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

100mg-1000s.jpg (100mg 1000s)

Sildenafil Tablets, USP 100 mg film-coated tablets packaging label from AustarPharma. The label shows the NDC 35561-253-14 with a quantity of 1000 tablets. It includes storage instructions, usage information, distributor details by AustarPharma LLC in Edison, NJ, and a barcode. The label also features a serialized data carrier area.*

FDA Label Image

100mg-30s.jpg (100mg 30s)

Sildenafil 100 mg tablets label from AustarPharma. The label states the product as Sildenafil Tablets, USP, 100 mg strength, with a package size of 30 tablets for prescription use only. Storage instructions specify 25°C with allowable excursions and protection from moisture. Distributor information lists AustarPharma LLC, Edison, NJ, USA.*

FDA Label Image

25mg-1000s.jpg (25mg 1000s)

Label for Sildenafil Tablets USP 25 mg by AustarPharma. The label indicates the quantity as 1000 tablets and specifies prescription use only (Rx Only). It includes storage instructions, dosage directions, and distributor information for AustarPharma LLC in Edison, NJ. The label also features a barcode and a note about an unvarnished serialized data carrier area.*

FDA Label Image

25mg-30s.jpg (25mg 30s)

Label for Sildenafil Tablets, USP 25 mg film-coated tablets by AustarPharma. The label indicates 30 tablets per package and prescription-only status. It includes storage instructions, dosage usage notes, manufacturer and distributor details, and a barcode. The label highlights the 25 mg strength in a blue box and the product NDC 35561-251-10.*

FDA Label Image

50mg-1000s.jpg (50mg 1000s)

Sildenafil Tablets, USP 50 mg film-coated tablets packaging label. The label shows a quantity of 1000 tablets, distributor AustarPharma LLC located in Edison, NJ, and storage instructions. It includes the NDC 35561-252-14 and states the product is Rx only. The label also notes that each tablet contains sildenafil citrate equivalent to 50 mg sildenafil.*

FDA Label Image

50mg-30s.jpg (50mg 30s)

Packaging label for Sildenafil Tablets USP 50 mg film-coated tablets by AustarPharma. The label states 30 tablets, prescription only, with storage instructions and manufacturer details including AustarPharma LLC, Edison, NJ.*

FDA Label Image

Figure1.jpg (Figure1)

A line graph showing the mean change from baseline in sitting systolic blood pressure over 24 hours in healthy volunteers. It compares Sildenafil 100 mg with a placebo, plotting changes in blood pressure (mmHg) against time post dose (hours), starting from pre-dose measurements.*

FDA Label Image

Figure2.jpg (Figure2)

A line graph titled 'Mean Standing Systolic Blood Pressure Change from Baseline' showing change in blood pressure (mm Hg) over 8 hours postdose. The graph compares two groups: Doxazosin versus Placebo (blue line) and Doxazosin plus Sildenafil 25 mg (black line). The y-axis represents blood pressure change and the x-axis represents time in hours.*

FDA Label Image

Figure3.jpg (Figure3)

A line graph titled 'Mean Standing Systolic Blood Pressure Change from Baseline' showing changes in systolic blood pressure over an 8-hour period postdose. Three lines represent Doxazosin plus placebo, Doxazosin plus Sildenafil 50 mg, and a third comparative data set, illustrating trends in blood pressure changes over time.*

FDA Label Image

Figure4.jpg (Figure4)

Figure 4 is a line graph showing the mean standing systolic blood pressure change from baseline over 8 hours after dosing. It compares blood pressure changes between subjects treated with Doxazosin plus Sildenafil 100 mg and those treated with Doxazosin plus placebo, using mmHg on the vertical axis and time after dosing (hours) on the horizontal axis.*

FDA Label Image

Figure5.jpg (Figure5)

A line graph depicting mean plasma concentrations of sildenafil over time in healthy male volunteers after administration of a commercial tablet. The x-axis represents time post dose in hours up to 24 hours, and the y-axis shows plasma concentration in ng/mL. The concentration peaks shortly after dosing and declines gradually over 24 hours.*

FDA Label Image

Figure6.jpg (Figure6)

A chart comparing the effect of Sildenafil and Placebo on maintenance of erection by baseline score. The top graph shows percentages of patients at endpoint by baseline score for Sildenafil, with bars representing different scores from 0 to 5. The bottom graph shows a similar comparison for Placebo. Both graphs include a legend for score values ranging from 0 to 5.*

FDA Label Image

Figure7.jpg (Figure7)

A bar chart titled 'Percentage of Patients Reporting an Improvement in Erections' showing data for four treatment groups: Placebo, Sildenafil 25 mg, Sildenafil 50 mg, and Sildenafil 100 mg. The chart presents the percentage of patients reporting improvement, increasing from 24% for placebo to 82% for sildenafil 100 mg, with intermediate values of 63% and 74% for 25 mg and 50 mg doses respectively. The chart includes sample sizes for each group and notes an overall treatment p-value <0.0001.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure diagram of sildenafil, showing its molecular framework with labeled functional groups including sulfonamide, methyl, and nitrogen-containing heterocycles.*

FDA Label Image

Table-2.jpg (Table 2)

Table showing adverse reactions reported by 2% or more of patients treated with Sildenafil compared to placebo in Phase II/III studies. It lists rates of headache, flushing, dyspepsia, nasal congestion, abnormal vision, back pain, dizziness, and rash for Sildenafil (N=734) and placebo (N=725). An explanatory footnote defines abnormal vision as mild, transient, and related to color tinge or blurred vision.*

FDA Label Image

Table-3.jpg (Table 3)

A data table titled 'Hemodynamic Data in Patients with Stable Ischemic Heart Disease after Intravenous Administration of 40 mg of Sildenafil.' The table shows mean values and standard deviations for various hemodynamic parameters including PAOP, mean PAP, mean RAP, systolic SAP, diastolic SAP, cardiac output, and heart rate. Data are presented for baseline and sildenafil conditions both at rest and after 4 minutes of exercise in patients, with sample sizes indicated.*

FDA Label Image

Table1.jpg (Table1)

A data table listing adverse reactions reported by 2% or more of patients treated with sildenafil at 25 mg, 50 mg, and 100 mg doses compared to placebo in fixed-dose Phase II/III studies. The table details percentage incidences of side effects such as headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash across the different dosage groups and placebo.*

* 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.