Sildenafil Citrate Powder, For Suspension
Product Images NDC 72205-059

22 FDA label images from Novadoz Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Sildenafil Citrate (NDC 72205-059). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novadoz Pharmaceuticals 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.

FDA Label Image

Bottle-label (Bottle Label)

Bottle-label (Bottle Label)
Label for sildenafil citrate oral suspension 10 mg/mL powder for suspension by Novadoz Pharmaceuticals LLC. The label states the product is for oral use only, to shake well before each use, and indicates a 112 mL volume following reconstitution. Instructions for storage before and after reconstitution and information on reconstitution with 90 mL water are included. The suspension is grape flavored and manufactured by MSN Pharmaceuticals Inc. in Piscataway, NJ.*
FDA Label Image

Carton-label (Carton Label)

Carton-label (Carton Label)
Packaging label for sildenafil citrate 10 mg/mL powder for oral suspension by Novadoz Pharmaceuticals LLC. The label includes storage instructions before and after reconstitution, directions for reconstituting the powder, and notes that the suspension is grape flavored. The package size is 112 mL following reconstitution, labeled Rx Only with NDC 72205-059-76. Manufacturer information lists MSN Pharmaceuticals Inc., Piscataway, NJ.*
FDA Label Image

Figure-1 (Figure 1)

Figure-1 (Figure 1)
An instructional diagram showing a syringe being filled from a medication bottle along with an image of a graduated cylinder. This likely illustrates the preparation or measurement steps for oral suspension medication dosing.*
FDA Label Image

Figure-10 (Figure 10)

Figure-10 (Figure 10)
A forest plot chart showing placebo-corrected changes in 6-minute walk distance (m) stratified by baseline walk distance, etiology, PH criteria for functional capacity and therapeutic class, gender, age, mean PAP, and PVRI. Each subgroup has data points with confidence intervals represented for sildenafil 20 mg TID compared to placebo.*
FDA Label Image

Figure-11 (Figure 11)

Figure-11 (Figure 11)
A Kaplan-Meier curve chart depicting the percentage of subjects without a clinically worsening event over a period of 112 days from randomization. The chart compares two groups: sildenafil and placebo, with sildenafil's line generally showing a higher percentage without worsening events compared to placebo.*
FDA Label Image

Figure-12 (Figure 12)

Figure-12 (Figure 12)
A line graph showing mean change from baseline in meters over 12 weeks for sildenafil at doses of 1 mg, 5 mg, and 20 mg taken three times daily (TID). The x-axis represents study weeks (4, 8, and 12), and the y-axis shows change from baseline in meters, with error bars indicating standard error. Higher doses show greater improvement over time.*
FDA Label Image

Figure-2 (Figure 2)

Figure-2 (Figure 2)
An instructional diagram showing how to prepare a suspension bottle: first, opening the child-resistant cap by pressing down and turning; second, shaking the bottle vertically and horizontally to mix contents; third, showing a stopwatch timed for approximately 30 seconds, indicating the recommended shaking duration.*
FDA Label Image

Figure-3 (Figure 3)

Figure-3 (Figure 3)
An instructional diagram showing a dosing bottle with a syringe for measuring liquid medication, likely illustrating administration or preparation of sildenafil citrate 10 mg/mL powder for suspension oral dosage form.*
FDA Label Image

Figure-4 (Figure 4)

Figure-4 (Figure 4)
An instructional illustration demonstrating proper handling of a medication bottle. The images show pressing down and turning the cap to open, shaking the bottle by moving it up and down and side to side, and a stopwatch with arrows indicating timing, likely for shaking duration or a waiting period before use.*
FDA Label Image

Figure-5 (Figure 5)

Figure-5 (Figure 5)
An instructional diagram showing how to close a bottle containing sildenafil citrate powder for suspension. The left side illustrates pressing down and inserting a stopper into the bottle neck. The right side depicts a hand turning the bottle cap clockwise to secure it.*
FDA Label Image

Figure-6 (Figure 6)

Figure-6 (Figure 6)
A Kaplan-Meier survival curve illustrating the estimated cumulative mortality rate (%) over time (years) for three dose groups: High Dose, Medium Dose, and Low Dose. The vertical axis represents cumulative mortality rate and the horizontal axis shows time in years. The number of subjects at risk decreases over time for each dose group.*
FDA Label Image

Figure-7 (Figure 7)

Figure-7 (Figure 7)
A horizontal dot plot chart showing fold change and 90% confidence intervals of pharmacokinetic parameters (AUC and Cmax) for sildenafil citrate when coadministered with various interacting drugs. The chart compares changes relative to sildenafil alone (vertical solid line at x=1) and includes dose adjustment recommendations for Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir.*
FDA Label Image

Figure-8 (Figure 8)

Figure-8 (Figure 8)
A chart showing fold change and 90% confidence intervals for pharmacokinetic parameters (INR, AUC, Cmax, BT) of sildenafil citrate when coadministered with various interacting drugs. The recommendations column indicates whether dose adjustment is needed, with most drugs requiring no dose adjustment except ritonavir, where coadministration is not recommended. The chart compares changes relative to interacting drugs alone, with a vertical reference line at 1.*
FDA Label Image

Figure-9 (Figure 9)

Figure-9 (Figure 9)
A line graph depicting change from baseline in meters over three time points: Week 4, Week 8, and Week 12. The x-axis represents the week of study, and the y-axis shows change from baseline ranging from -20 to 80 meters. The graph compares four groups: Placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID. Data points include error bars indicating variability.*
FDA Label Image

Figure-a (Figure A)

Figure-a (Figure A)
An instructional diagram illustrating the components of a sildenafil citrate oral suspension bottle and an oral syringe. The bottle is shown with a cap and syringe adaptor. The oral syringe is labeled with a tip, barrel marked with volume measurements, and a plunger for dosing.*
FDA Label Image

Figure-b (Figure B)

Figure-b (Figure B)
Illustration showing instructions to shake a bottle of sildenafil citrate powder for suspension, for oral use. The diagram includes a bottle being moved up and down and rotated, a stopwatch showing 10 seconds, and the bottle cap being pressed down and turned to open or close.*
FDA Label Image

Figure-c (Figure C)

Figure-c (Figure C)
An instructional illustration labeled Figure C showing a hand holding a vial with liquid inside. Another hand is inserting a syringe into the vial's stopper, indicating how to draw liquid from the vial for oral suspension preparation or dosing.*
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Figure-d (Figure D)

Figure-d (Figure D)
An instructional illustration labeled Figure D showing hands holding an upside-down bottle with liquid inside. Below the bottle is a syringe measuring 2 mL, with an arrow pointing downward indicating liquid withdrawal from the bottle into the syringe. This suggests a step in preparing an oral suspension dose.*
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Figure-e (Figure E)

Figure-e (Figure E)
An instructional illustration showing the use of a syringe to withdraw liquid from a bottle. The syringe is being pulled upward from the bottle's neck, with measurement markings visible on the syringe barrel.*
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Figure-f (Figure F)

Figure-f (Figure F)
An instructional line drawing showing a syringe being administered orally into an open mouth, labeled as Figure F. The image likely illustrates the proper oral administration technique for a liquid or suspension medication using a syringe.*
FDA Label Image

Figure-g (Figure G)

Figure-g (Figure G)
An instructional diagram labeled Figure G showing a faucet with water flowing into two syringes, one with 2 ml and 0.6 ml marks visible. The illustration likely demonstrates measuring or mixing liquid but contains no product-specific text or branding.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure of sildenafil citrate showing its molecular arrangement including key functional groups and bonds.*

* 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.