Sildenafil Citrate Powder, For Suspension
Product Images NDC 59651-420

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Sildenafil Citrate (NDC 59651-420). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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.

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Figure (Sildenafil Fig 20)

This is a description of an oral suspension of Sildenafil citrate which is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. Before reconstitution, each mL of the suspension contains 10 mg of Sildenafil citrate. Once reconstituted with 90 mL of water, it becomes 1.57 g of Sildenafil citrate USP (1:42 g Sildenafil). This medication is distributed by Aurobindo Pharma USA Inc. It must be stored below 30°C (86°F) before and after reconstitution in its original packaging to protect it from moisture. After reconstitution, it can also be stored in the refrigerator at 2°to 8°C (36° to 46°F). The recommended dosage depends on the prescribing information. The oral suspension bottle contains 112 mL of grape-flavored liquid, and the medication must be discarded 60 days after reconstitution. The package has a printing zone coding area of 45x20 mm.*

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Figure (Sildenafil Fig 21)

This is a medication called Sildenafil for oral use only. It is a grape-flavored suspension that comes in a 112 mL bottle that needs to be reconstituted with 90 mL of water. Each mL of the suspension contains 10 mg of sildenafil citrate. The recommended storage for the medication is below 30°C in the original package to protect from moisture. The reconstituted suspension can be stored below 30°C or in the refrigerator between 2° and 8°C. The unused portion of the suspension should be discarded 60 days after reconstitution. The medication should be taken as per the prescriber's instructions. It comes with an oral dosing syringe and a press-in bottle adapter. The medication is manufactured by Aurobindo Pharma in India.*

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Figure 1 (Sildenafil Fig1)

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Figure 10. Placebo-corrected Change From Baseline In 6-minute Walk Distance (meters) At Week 12 By Study Subpopulation In Study 1: Mean (95% Confidence Interval) (Sildenafil Fig10)

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Figure 11. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Sildenafil Fig11)

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Figure 12. Mean Change From Baseline In Six Minute Walk (meters) By Visit To Week 12 – Itt Population Sildenafil Protocol A1481244 (Sildenafil Fig12)

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Figure A (Sildenafil Fig13)

This appears to be a product label for a bottle of sildenafil oral suspension. The label includes an image (Figure A) and mentions a plunger and tip, likely for administering the medication.*

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Figure B (Sildenafil Fig14)

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Figure C (Sildenafil Fig15)

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Figure D (Sildenafil Fig16)

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Figure E (Sildenafil Fig17)

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Figure F (Sildenafil Fig18)

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Figure G (Sildenafil Fig19)

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Figure 2 (Sildenafil Fig2)

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Figure 3 (Sildenafil Fig3)

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Figure 4 (Sildenafil Fig4)

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Figure 5 (Sildenafil Fig5)

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Figure 6 (Sildenafil Fig6)

The text represents a chart or graph showing the estimated cumulative mortality rate of individuals at risk over time, separated by different dosage categories. The dosage categories include high, medium, and low doses, each indicating a different percentage of mortality rate. The x-axis indicates time in years.*

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Figure 7 (Sildenafil Fig7)

This is a medical document discussing the effects of various drugs on AUC and Cmax values. The document provides recommendations for interacting drugs such as Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Oral Contraceptives, Ritonavir and Saquinavir. It also includes a chart showing changes in AUC values and provides notes regarding an interaction between Sildenafil and Bosentan.*

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Figure 8 (Sildenafil Fig8)

This appears to be a list of different drugs and their interactions with other drugs. It specifies whether any dose adjustments are necessary when taking these drugs alongside other drugs. In some cases, certain combinations are not recommended. It also includes a note about the effect of ritonavir on sildenafil PK, and advises that adding sildenafil to bosentan therapy may have no benefit on exercise capacity.*

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Figure 9. Change From Baseline In 6-minute Walk Distance (meters) At Weeks 4, 8, And 12 In Study 1: Mean (95% Confidence Interval) (Sildenafil Fig9)

This appears to be a table showing changes in meters at different weeks of a study with different dosages of a drug called Sildenafil. The dosages mentioned are 20 mg TID, 40 mg TID, and 80 mg TID. The study appears to have lasted for 12 weeks, with measurements taken at week 4, week 8, and week 12. However, without additional context and information, it is unclear what the study was investigating or what the changes in meters represent.*

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Chemical Structure (Sildenafil Str)

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