Sildenafil Powder, For Suspension
Product Images NDC 68180-283

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 68180-283). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin Pharmaceuticals, Inc., 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

Image 1 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 01)

An instructional diagram showing a measuring cylinder on the left, a medicine vial partially filled with liquid labeled as Figure 1 in the center, and an oral dosing syringe on the right marked 'x1' indicating one dose measurement. This image likely demonstrates preparation or measurement steps for oral suspension administration.*

FDA Label Image

Image 2 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 02)

An instructional illustration showing steps to prepare a liquid medication from a vial. It depicts twisting off a cap, shaking the vial up and down to mix the contents, and a stopwatch indicating timing. This likely supports proper reconstitution or use instructions for the suspension.*

FDA Label Image

Image 3 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 03)

An instructional illustration showing a graduated cylinder, a dosing syringe marked with volume increments, and a small bottle containing liquid. The image demonstrates measuring and administering one unit dose of an oral suspension medication.*

FDA Label Image

Image 4 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 04)

An instructional illustration showing three steps for preparing an oral suspension: first, pressing and turning the bottle cap to open; second, shaking the bottle vigorously up and down; third, timing the process with a stopwatch showing about 45 seconds elapsed.*

FDA Label Image

Image 5 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 05)

An instructional illustration showing two steps to prepare a suspension. The first step depicts inserting a measuring spool into an open bottle, and the second step shows twisting the cap on the bottle to secure it before shaking. This is likely related to the preparation of an oral suspension formulation.*

FDA Label Image

Image 6 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 06)

A Kaplan-Meier survival curve chart showing estimated cumulative mortality rate (%) over a 5-year period. The graph displays three dose groups labeled High Dose, Medium Dose, and Low Dose, with stepwise lines indicating mortality trends for each group. A table at the top lists the number of patients at risk at different time points for each dose group.*

FDA Label Image

Image (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 07)

Chemical structure of Sildenafil, the active ingredient in Sildenafil powder for suspension oral dosage form. The diagram shows the compound's molecular arrangement with labeled atoms and functional groups.*

FDA Label Image

Image 7 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 08)

A chart showing fold change and 90% confidence intervals in AUC and Cmax for various interacting drugs relative to Sildenafil alone. It includes recommendations for dose adjustment, mostly indicating no dose adjustment except for Ritonavir, where coadministration is not recommended. Drugs analyzed include Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir.*

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Image 8 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 09)

A chart showing fold changes and 90% confidence intervals in pharmacokinetic parameters (INR, AUC, Cmax, bleeding time) for various drugs when interacting with sildenafil. The chart includes drugs like Acenocoumarol, Aspirin, Atorvastatin, Bosentan, Doxazosin, Ethinyloestradiol, Levonorgestrel, Phenprocoumon, Ritonavir, Saquinavir, and Tolbutamide, along with dose adjustment recommendations for each interaction.*

FDA Label Image

Image 9 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 10)

A line graph depicting change from baseline in meters over a 12-week study period. The x-axis represents the study weeks (Week 4, Week 8, Week 12), and the y-axis shows the change from baseline in meters. Different symbols indicate groups: placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID, with error bars illustrating variability.*

FDA Label Image

Figure 10 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 11)

A forest plot showing the placebo-corrected change in 6-minute walk distance in meters for Sildenafil 20 mg TID across various patient subgroups, including baseline walk distance, etiology, PH criteria, gender, age, mean PAP, and PVRI. The graph includes numeric counts for placebo and Sildenafil groups on the left and horizontal error bars representing confidence intervals on the right.*

FDA Label Image

Image 11 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 12)

A line graph showing the percentage of participants without a clinically worsening event over time in days from randomization. The graph compares two groups: Placebo (solid line) and Sildenafil (dashed line), with the Sildenafil group maintaining a higher percentage over the 112-day period.*

FDA Label Image

Image 12 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 13)

A line chart comparing the mean change from baseline in meters over 12 weeks for three Sildenafil treatments: Sildenafil 1mg TID, Sildenafil 5mg TID, and Sildenafil 20mg TID. The chart includes error bars representing standard error for each treatment at weeks 4, 8, and 12.*

FDA Label Image

Image 13 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 14)

Illustration showing components of a Sildenafil oral suspension dosing kit, including a bottle with a cap and syringe adaptor, and a syringe with labeled tip, barrel, and plunger, marked with dosing volumes of 0.5 mL and 2 mL.*

FDA Label Image

Image 14 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 15)

An instructional illustration showing three steps for preparing a suspension medication: shaking the bottle with an up-and-down and circular motion, timing 30 seconds with a stopwatch, and pressing down and twisting off the bottle cap.*

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Image 15 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 16)

An instructional illustration showing hands using a syringe to draw liquid from a bottle. One hand holds the bottle steadily while the other hand pushes the syringe plunger down into the vial, with an arrow indicating downward motion. This image likely demonstrates how to draw the powder-for-suspension medication for oral use.*

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Image 16 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 17)

An instructional black-and-white line drawing showing a hand holding an open suspension bottle upside down while drawing liquid into a syringe. The hands are positioned to indicate how to fill the syringe from the bottle, with an arrow pointing downward indicating the syringe plunger movement.*

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Image 17 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 18)

An instructional illustration depicting a syringe inserted into the neck of a bottle, with a vertical arrow pointing upward beside the syringe, indicating withdrawal of liquid. The syringe is marked with volume measurements and appears to be drawing powder for suspension product from the bottle.*

FDA Label Image

Image 18 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 19)

An instructional illustration showing the oral administration of medication using a syringe. The syringe is positioned near the mouth, indicating how to deliver a liquid medication by oral route, relevant for powder for suspension dosage forms like Sildenafil oral suspension.*

FDA Label Image

Image 19 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 20)

An instructional line drawing showing a faucet with two oral syringes positioned under its spout, likely illustrating how to fill the syringes with liquid medication for oral administration.*

FDA Label Image

Image 20 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 21)

Label for Sildenafil for Oral Suspension 10 mg/mL powder for suspension, oral use. The 112 mL container is prescription only, manufactured by Lupin Pharmaceuticals, Inc. The label includes storage instructions, dosing notes, and a barcode, indicating the product is grape flavored and should be shaken before use.*

FDA Label Image

Image 21 (F0441ca2 31d9 4d0f 9d12 Be68c9d39666 22)

Label for Sildenafil for Oral Suspension 10 mg/mL powder for suspension by Lupin Pharmaceuticals, Inc. The label states the product is for oral use, grape flavored, 112 mL following reconstitution. It includes storage and reconstitution instructions, dosage guidance, and manufacturer information showing Lupin Limited, India, and Lupin Pharmaceuticals, Baltimore, Maryland, USA. NDC 68180-283-01 is visible.*

* 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.