Rivaroxaban Tablet, Film Coated
Product Images NDC 50228-513

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 50228-513). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sciegen 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

180 Tablets-label (180 Tablets Label)

Rivaroxaban Tablets, USP 2.5 mg film-coated oral tablets label by ScieGen Pharmaceuticals, Inc. The label displays a single tablet image, strength 2.5 mg, quantity of 180 tablets, and a barcode. It includes storage instructions and a note to dispense the Medication Guide. Product NDC 50228-513.*

FDA Label Image

Fig_10.jpg (Fig 10)

A line graph showing cumulative incidence rate (%) on the y-axis against days from randomization on the x-axis for Rivaroxaban and placebo treatment groups. The graph compares incidence rates over time, with two lines representing Rivaroxaban (solid line) and placebo (dashed line). The lower cumulative incidence rate is shown for the Rivaroxaban group compared to placebo. A table displays the number of subjects at risk at various time points for each group, and a hazard ratio with confidence interval is noted for comparison.*

FDA Label Image

Fig_11.jpg (Fig 11)

A cumulative incidence rate chart showing the percentage of events over days from randomization for Rivaroxaban compared to placebo. The graph includes hazard ratio data comparing Rivaroxaban with placebo, with lower incidence rates for Rivaroxaban. It also shows the number of subjects at risk over time for both groups.*

FDA Label Image

Fig_12.jpg (Fig 12)

A forest plot graph comparing the efficacy outcomes of Rivaroxaban 2.5 mg versus placebo across various patient subgroups. The graph displays hazard ratios (HR) with 95% confidence intervals for factors such as age, sex, weight, baseline diabetes, coronary artery disease, and history of revascularization. Each subgroup is represented by a square and horizontal line, illustrating the relative favorability of Rivaroxaban or placebo.*

FDA Label Image

Fig_2.jpg (Fig 2)

A forest plot chart showing the fold change and 90% confidence interval for pharmacokinetic parameters (Cmax and AUC) of rivaroxaban in various populations including end-stage renal disease, different levels of renal impairment, age groups, body weight categories, and hepatic impairment. The x-axis represents the change relative to reference, ranging approximately from 0.5 to 3.1 fold change.*

FDA Label Image

Fig_3.jpg (Fig 3)

A data table showing the pharmacokinetic fold change and 90% confidence intervals for various interacting drugs with Rivaroxaban. The table is divided into categories such as Combined P-gp and Strong CYP3A Inhibitors, Combined P-gp and Moderate CYP3A Inhibitor, Moderate CYP3A Inhibitor, Combined P-gp and Strong CYP3A Inducer, and Other Drugs. It depicts changes in Cmax and AUC relative to Rivaroxaban alone.*

FDA Label Image

Fig_9.jpg (Fig 9)

A line graph comparing the cumulative incidence rate (%) over days from randomization between Rivaroxaban and Placebo groups. The solid line represents Rivaroxaban, and the dashed line represents Placebo. The x-axis shows days up to 1095, and the y-axis shows the cumulative incidence rate up to 10%. A table below the graph lists the number of subjects at risk at various time points for both groups. A hazard ratio for Rivaroxaban versus Placebo is also displayed.*

FDA Label Image

Rivaroxaban Structure.jpg (Rivaroxaban Structure)

Chemical structure of rivaroxaban, showing its molecular arrangement with identifiable chemical bonds and ring structures.*

FDA Label Image

Label_60 Tablets (Label 60 Tablets)

Label for Rivaroxaban Tablets, USP 2.5 mg by ScieGen Pharmaceuticals, Inc. The label indicates each tablet contains 2.5 mg rivaroxaban and the package contains 60 film-coated tablets. Storage instructions specify room temperature 20°C to 25°C with allowable excursions. The label includes a barcode, NDC 50228-513-60, and advises dispensing the medication guide with the product.*

* 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.