Revatio Powder, For Suspension
Product Images NDC 58151-385

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Revatio (NDC 58151-385). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Viatris Specialty 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.

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Instructions For Use Figure A (Image 01)

An instructional illustration showing the components and labeling of a Revatio oral suspension bottle and an oral dosing syringe. The bottle includes labeled parts such as cap, bottle adaptor, and a discard after date. The syringe is labeled with parts including tip, barrel with volume markings, and plunger.*

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Instructions For Use Figure B (Image 02)

An instructional diagram showing a hand holding and rotating a bottle cap in different directions, alongside a stopwatch displaying elapsed time, likely illustrating proper handling or preparation steps for an intravenous injection solution.*

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Instructions For Use Figure C (Image 03)

An instructional illustration labeled Figure C shows a hand gripping and lifting the cap off a vial, indicating the direction to remove the cap. The vial is partially filled and has an arrow pointing horizontally on its body, likely indicating alignment or unlocking direction. No text about the product is visible.*

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Instructions For Use Figure D (Image 04)

An instructional illustration showing a person drawing medication from a vial using a syringe. The image demonstrates pressing down the syringe plunger while the vial is held steady, indicating the procedure for withdrawing an intravenous injection solution.*

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Instructions For Use Figure E (Image 05)

An instructional diagram showing the proper technique for drawing liquid from an IV infusion bottle into a syringe. The image focuses on the hand positioning and syringe placement to correctly withdraw the intravenous injectable solution.*

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Instructions For Use Figure F (Image 06)

Instructional illustration showing hands drawing liquid from a bottle using a syringe, with an upward arrow indicating the withdrawal motion. The figure is labeled 'Figure F' and likely demonstrates the preparation step for an intravenous injection.*

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Instructions For Use Figure G (Image 07)

An instructional illustration showing the administration of an oral syringe to an adult and a child. The left side depicts an adult receiving the syringe in the mouth with an arrow indicating the direction of administration. The right side shows a child in a reclining position with the syringe being administered into the mouth, also indicated by an arrow.*

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Instructions For Use Figure H (Image 08)

An instructional illustration labeled Figure H showing a hand gripping and twisting the cap of a medication vial, indicating the cap removal or securing action.*

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Instructions For Use Figure I (Image 09)

An instructional diagram showing a water faucet with water flowing into a syringe positioned under the spout. Below the syringe is a vial lying horizontally. The figure demonstrates how to fill the syringe with liquid, likely for preparing an intravenous injection.*

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Sildenafil Citrate Structural Formula (Image 10)

Chemical structure of sildenafil citrate, the active ingredient in Revatio injection, solution for intravenous use by Viatris Specialty LLC.*

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Figure 1. Effects Of Other Drugs On Sildenafil Pharmacokinetics (Image 11)

A chart depicting fold changes and 90% confidence intervals in AUC and Cmax for various drugs interacting with sildenafil, including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, oral contraceptives, Ritonavir, and Saquinavir. The chart shows recommendations for dose adjustments, with some drugs advised as 'No dose adjustment' and others noting 'Coadministration not recommended.' The x-axis displays change relative to sildenafil alone from 0.2 to 13-fold.*

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Figure 2. Effects Of Sildenafil On Other Drugs (Image 12)

A forest plot chart showing fold change and 90% confidence intervals for various interacting drugs with sildenafil citrate. The chart compares changes in INR, AUC, Cmax, and bleeding time for drugs including Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin, Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide. It includes recommendations on dose adjustments and notes that coadministration with bosentan and ritonavir is not recommended.*

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Figure 3. Change From Baseline In 6-minute Walk Distance (meters) At Weeks 4, 8, And 12 In Super-1: Mean (95% Confidence Interval) (Image 13)

A line graph depicting change from baseline in meters over weeks 4, 8, and 12 of a study. The graph compares four groups: placebo and sildenafil dosed at 20 mg TID, 40 mg TID, and 80 mg TID, with data points showing mean changes and error bars representing variability.*

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Figure 4. Placebo-corrected Change From Baseline In 6-minute Walk Distance (meters) At Week 12 By Study Subpopulation In Super-1: Mean (95% Confidence Interval) (Image 14)

A forest plot graph depicting placebo-corrected change in 6-minute walk distance in meters for patients treated with Sildenafil 20 mg TID versus placebo, categorized by baseline walk distance, etiology (idiopathic PAH, PAH-CTD, PAH-surgical repair), pulmonary hypertension criteria, gender, age, mean pulmonary artery pressure, and PVRI. The graph presents group sizes and confidence intervals for each subgroup comparison.*

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Figure 5. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Paces-1 (Image 15)

A line graph depicting percentage without a clinically worsening event over time in days from randomization, comparing Sildenafil and Placebo groups. The x-axis represents days, and the y-axis shows the percentage without worsening events. The Sildenafil group shows higher survival without worsening compared to Placebo throughout the study period.*

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Figure 6. Percentage Change From Baseline In Vo2peak: Mean (95% Confidence Intervals) (Image 16)

A bar graph showing the percentage change in VO2peak across different treatment groups including Placebo, Low Dose, Medium Dose, High Dose, and Combined Doses. The x-axis represents the treatment groups, and the y-axis represents the percentage change.*

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Bottle Label Revatio 20 mg (Image 17)

Revatio (sildenafil) 20 mg tablets packaging label showing a 90-tablet count. The label indicates prescription-only status, lists Viatris Specialty LLC as the distributor, and includes storage instructions. The label also features a barcode, NDC number 58151-402-77, and the Viatris logo.*

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Carton Label Revatio 10 mg/12.5 mL (Image 18)

Label for Revatio (sildenafil) Injection 10 mg/12.5 mL (0.8 mg/mL) sterile single-dose vial for intravenous use. The label states storage instructions, dosage form, manufacturer Viatris Specialty LLC, and the product is made in France. It includes barcodes, lot and expiry placeholders, and trademark information.*

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Carton Label Revatio 10 mg/ml (Image 19)

Revatio 10 mg/mL oral suspension carton label showing 112 mL reconstituted volume, grape flavored. Label states it is for oral use only with instructions to shake well before use. Distributed by Viatris Specialty LLC, the box includes storage and reconstitution directions, recommended dosage references, and barcode.*

* 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.