Sildenafil Citrate Powder, For Suspension
Product Images NDC 70771-1668

Product Visual Gallery

This gallery contains 24 technical images submitted to the FDA as part of the official labeling for Sildenafil Citrate (NDC 70771-1668). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Lifesciences 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

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An instructional illustration showing a measuring cylinder, a vial partially filled with liquid, and a syringe marked with measurement lines. The image likely depicts measuring and drawing up the suspension for oral administration.*

FDA Label Image

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An instructional diagram showing three steps for preparing a powder for suspension oral liquid. The first image depicts twisting a bottle cap to open it. The second shows holding the bottle and shaking it up and down with a circular motion. The third image includes a stopwatch, indicating a waiting or timing step.*

FDA Label Image

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An instructional diagram showing a bottle filled partially with liquid, alongside a graduated cylinder and a syringe marked with measurements, likely illustrating preparation or dosing instructions for oral suspension.*

FDA Label Image

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An instructional diagram showing three steps for preparing a bottle of liquid medication: pressing and turning the cap to open, shaking the bottle up and down, and a stopwatch illustrating timing, likely for measuring or waiting after shaking.*

FDA Label Image

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An instructional illustration showing two steps for opening a bottle. The first step depicts pressing down on the cap to remove it from the bottle. The second step shows twisting the cap to open the bottle completely. The bottle likely contains an oral suspension.*

FDA Label Image

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A Kaplan-Meier curve graph showing estimated cumulative mortality rate (%) over time in years for three dose groups labeled High Dose, Medium Dose, and Low Dose of Sildenafil Citrate powder for suspension. The graph includes a stepwise curve for each dose group and a table of numbers at risk at multiple time points along the x-axis.*

FDA Label Image

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Chemical structure of sildenafil citrate, showing its molecular components and bonding arrangement as part of the FDA SPL submission for the drug.*

FDA Label Image

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A graph showing fold change and 90% confidence intervals (CI) of drug interactions with Sildenafil Citrate. It compares area under the curve (AUC) and peak concentration (Cmax) for several interacting drugs including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. Recommendations on dose adjustments are listed, with most indicating no dose adjustment except for Ritonavir, where coadministration is not recommended.*

FDA Label Image

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A plot showing the fold change and 90% confidence intervals of various pharmacokinetic parameters (AUC, Cmax, INR, BT) for drugs interacting with sildenafil citrate. The x-axis represents the change relative to the interacting drug alone, with a vertical line at 1 indicating no change. The chart includes multiple drugs such as Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin (three doses), Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide, along with dosing and comments on dose adjustment recommendations.*

FDA Label Image

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A line graph depicting change from baseline over 12 weeks in meters for different doses of Sildenafil (20 mg TID, 40 mg TID, 80 mg TID) compared to placebo. The x-axis represents the week of study (Week 4, 8, 12) and the y-axis shows change from baseline in meters. Error bars indicate variability for each data point.*

FDA Label Image

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A forest plot showing placebo-corrected change in 6-minute walk distance (meters) for Sildenafil 20 mg TID across subgroups based on baseline walk distance, etiology, PH criteria, gender, age, mean pulmonary artery pressure (PAP), and pulmonary vascular resistance index (PVRI). The plot displays effect estimates with confidence intervals for each subgroup, illustrating variability in response to treatment compared to placebo.*

FDA Label Image

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A Kaplan-Meier survival curve graph showing the percentage of subjects without a clinically worsening event over time from randomization (days 0 to 112). The graph includes two curves: one for Sildenafil and one for Placebo, with Sildenafil's curve generally maintaining a higher percentage over time compared to Placebo.*

FDA Label Image

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A line plot showing mean change from baseline in meters over a 12-week study period for Sildenafil at 1 mg, 5 mg, and 20 mg taken three times daily (TID). The x-axis represents weeks of study (4, 8, 12), and the y-axis shows change from baseline in meters. Data points include standard error bars for each treatment group at each time point.*

FDA Label Image

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An instructional illustration showing a bottle of sildenafil for oral suspension with a removable cap and syringe adaptor. It also labels parts of an oral syringe including the tip, barrel with volume markings (0.5 mL and 2 mL), and plunger for measuring and administering the suspension.*

FDA Label Image

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An instructional diagram showing three steps: shaking a bottle vertically and horizontally, using a stopwatch or timer, and activating a dropper or dispenser mechanism, likely demonstrating preparation or administration steps for an oral suspension medication.*

FDA Label Image

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An instructional illustration showing the process of opening or attaching a component to a bottle, likely related to preparing or using a pharmaceutical product. The image shows a hand holding the bottle and another hand manipulating the cap or stopper above it, with directional arrows indicating the motion.*

FDA Label Image

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An instructional line drawing illustrating the preparation or administration of an oral suspension using a powder for suspension bottle. The image shows a hand holding the bottle upside down above a dosing syringe or measuring device, indicating the process of withdrawing the suspension dose for oral use.*

FDA Label Image

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An instructional diagram showing a syringe being inserted into the top of a bottle with an upward arrow indicating the direction to pull or extract liquid. The image suggests drawing medication from the bottle using the syringe, relevant for the administration of oral suspension products.*

FDA Label Image

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An instructional diagram showing a syringe being used to administer oral medication into a patient's mouth. The illustration depicts the nose and mouth of a person with the syringe positioned near the lips, indicating oral delivery of the dose.*

FDA Label Image

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An instructional line drawing showing an oral syringe being filled with liquid from a tap or faucet. The syringe is held under the tap's spout, and drops of liquid are depicted flowing from the tap into the syringe.*

FDA Label Image

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Label for Sildenafil for Oral Suspension 10 mg/mL by Zydus Pharmaceuticals. The label indicates a 112 mL liquid dosage form to be reconstituted. It includes instructions to shake well before use, for oral use only, and notes the product is prescription-only. The label also provides storage and safety information and states the suspension is grape flavored.*

FDA Label Image

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Sildenafil Citrate 10 mg/mL oral suspension powder packaging label. The label indicates the product is for oral use only, grape flavored, and should be shaken well before use. It includes reconstitution directions for adding water to the powder to make 112 mL suspension. The labeler is Zydus Lifesciences Limited, and the product includes storage instructions and recommended handling before and after reconstitution. The label also features the NDC 70771-1668-4 and bar code.*

FDA Label Image

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Label for Sildenafil for Oral Suspension 10 mg/mL, a powder for suspension oral dosage form. The label displays the NDC 70771-1668-5 and states to shake well before use. The package size is 112 mL following reconstitution. The label includes usage and storage instructions, child-resistant packaging notice, and manufacturer information: Cadila Healthcare Ltd., India. It is labeled for Rx only and is grape flavored.*

FDA Label Image

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Packaging label for Sildenafil for Oral Suspension 10 mg/mL powder for suspension by Zydus Lifesciences Limited. The label indicates a grape-flavored oral suspension with a total volume of 112 mL following reconstitution. It includes reconstitution directions, storage instructions, and dosing information, noting the product is for oral use only and should be shaken before use. The NDC is 70771-1668-5.*

* 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.