Sildenafil Tablet, Film Coated
Product Images NDC 13668-185

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 13668-185). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Torrent 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

2 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 01)

This text appears to be a chart showing estimated cumulative mortality rates at different doses over time. The doses are labeled as high dose, medium dose, and low dose, with corresponding percentages of estimated cumulative mortality rates given for each dose at different time intervals. However, the chart seems incomplete and lacks information to provide a full context.*

FDA Label Image

1 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 02)

FDA Label Image

7 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 03)

This appears to be a drug interaction chart showing the fold change in drugs and the recommended dose adjustments with a 90% confidence interval. It includes drugs like Atorvastatin, Adithromyein, Bosentan, Cimetidine, Mes, Erymromycin, Maslox, Oral Contraceptives, Rioravir, and Saquinavir. The chart also notes that co-administration of Rioravir with Sildenafil is not recommended. Additionally, there is a note about exercise capacity and the combination of Bosentan and Sildenafil in clinical studies.*

FDA Label Image

8 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 04)

This text appears to be a list of drugs and their interactions with Acenocoumarol. The text provides information about the effect of these drugs on the INR AUC and Cmax values, as well as any necessary dose adjustments. The text also lists Tolbutamide as one of the interacting drugs but does not indicate any effect on INR values or dose adjustments. The last line mentions a clinical study that found no benefit on exercise capacity when Sidonati is added to Bosantan therapy.*

FDA Label Image

4 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 05)

This is a table with the "Change from Baseline" values in meters for a clinical study conducted over 12 weeks. The study compared the effectiveness of different doses of Sildenafil (20mg, 40mg, and 80mg taken three times a day) against a placebo in an unrevealed condition. The table lacks clarity and context, and apparently, the software did not identify some visible character/symbol on the Week 4 column header.*

FDA Label Image

5 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 06)

The text is describing a clinical study of idiopathic PAH with the use of Placebo and Sildenafil 20 mg TID. It includes baseline walk distance and criteria for function capacity. There is also information about the gender and age of patients, as well as Median PAP in mmHg. The placebo-corrected change in 6-Minute Walk Distance (m) is plotted on a graph.*

FDA Label Image

1 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 07)

FDA Label Image

Figure 12 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 08)

The given text is a description of a graph labeled as "Figure 12", related to 'Sildenafil Protocol A1481244'. The graph displays the mean change (in meters) from baseline for a Six Minute Walk Test for different doses of sildenafil (1mg TID, 5mg TID, and 20mg TID) up to the 12th week. The graph shows the standard error as well.*

FDA Label Image

9 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 09)

FDA Label Image

9 (55aa9711 6df5 4516 Bf00 A1acf7f7a464 10)

FDA Label Image

Label (55aa9711 6df5 4516 Bf00 A1acf7f7a464 11)

This text describes a pharmaceutical product called Sildenafil. Each film-coated tablet includes 20 g of sildenafil citrate USP, and they should be stored at temperatures between 15°C and 30°C in a tightly closed container with a child-resistant closure. The usual dosage and prescribing information should be followed, and a Patient Information Sheet should be provided to each patient. The product is manufactured by Torrent Pharmaceuticals LTD in India and is distributed by Torrent Pharma Inc. in Levitiown, PA.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.