Xarelto Tablet, Film Coated
Product Images NDC 50090-4468

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Xarelto (NDC 50090-4468). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by A-s Medication Solutions, 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

Label Image (Lbl500904468)

Xarelto 20 mg film-coated tablets packaging label from A-S Medication Solutions. The label states each tablet contains 20 mg of rivaroxaban, with a total count of 90 tablets per package. Storage instructions note to keep the product at 77 degrees Fahrenheit or room temperature. The label also includes NDC 50090-4468-0 and a barcode with additional dosage packaging information.*

FDA Label Image

Figure 1 (Xarelto 01)

A forest plot chart comparing the hazard ratio and 95% confidence intervals for rivaroxaban versus warfarin across various patient subgroups. Categories include prior warfarin use, age ranges, gender, weight, prior stroke/TIA, diabetic status, CHADS2 score, creatinine clearance levels, geographic region, and aspirin use at randomization. The chart visually depicts whether each subgroup favors rivaroxaban or warfarin based on the hazard ratio values.*

FDA Label Image

Figure 2 (Xarelto 02)

A forest plot comparing the risk of major bleeding with Xarelto plus aspirin versus aspirin alone across various subgroups including age, sex, region, weight, kidney function (eGFR), medical history, and comorbidities. The plot shows hazard ratios with 95% confidence intervals for each subgroup, indicating relative risk differences between treatment groups.*

FDA Label Image

Chemical Structure (Xarelto 03)

Chemical structure of rivaroxaban, the active ingredient in Xarelto 20 mg film-coated tablets. The diagram shows the molecular arrangement with rings and functional groups characteristic of rivaroxaban.*

FDA Label Image

Figure 3 (Xarelto 04)

A pharmacokinetic (PK) fold change chart displaying Cmax and AUC values with 90% confidence intervals for different population groups relative to a reference. Groups include End-Stage Renal Disease (postdialysis/normal), varying degrees of Renal Impairment (severe, moderate, mild), Age (75-83 years vs 18-43 years), Body Weight categories (<=50 kg, >120 kg compared to 70-80 kg), and Hepatic Impairment (moderate and mild versus normal). The x-axis shows change relative to reference.*

FDA Label Image

Figure 4 (Xarelto 05)

A pharmacokinetic chart depicting fold change and 90% confidence intervals for various interacting drugs on rivaroxaban's Cmax and AUC. The graph includes combined P-gp and strong or moderate CYP3A inhibitors and inducers, as well as other drugs like aspirin, atorvastatin, clopidogrel, digoxin, and warfarin, showing their relative changes compared to rivaroxaban alone.*

FDA Label Image

Figure 5 (Xarelto 06)

A Kaplan-Meier curve chart comparing cumulative event rates over time between Xarelto and Warfarin. The x-axis shows days from randomization up to 900 days, and the y-axis shows cumulative event rates in percentage. The chart includes the number of subjects at risk for both groups at various time points and reports a hazard ratio (HR) with 95% confidence interval (CI).*

FDA Label Image

Figure 6 (Xarelto 07)

A forest plot comparing hazard ratios with 95% confidence intervals for rivaroxaban versus warfarin across various patient subgroups, including age, gender, weight, prior stroke/TIA, diabetic status, CHA2DS2 score, kidney function, geographic region, and ASA use at randomization. The plot visually displays the favorability of each drug within these categories.*

FDA Label Image

Figure 7 (Xarelto 08)

A line graph comparing cumulative event rates (%) over days from randomization for Xarelto (rivaroxaban) and Enoxaparin/VKA. The x-axis shows days up to 360, and the y-axis shows cumulative event rate up to 4%. Xarelto's event rate line is lower than Enoxaparin/VKA's throughout the study period, with patient risk numbers noted below the graph.*

FDA Label Image

Figure 8 (Xarelto 09)

A cumulative event rate line graph comparing Xarelto (rivaroxaban) with Enoxaparin/VKA over 360 days from randomization. The y-axis shows cumulative event rate percentage, and the x-axis shows time in days. The graph includes patient numbers at risk for both drugs at various timepoints and a hazard ratio (HR) with 95% confidence interval.*

FDA Label Image

Figure 9 (Xarelto 10)

A Kaplan-Meier cumulative event rate plot comparing Xarelto and Aspirin over 367 days from randomization. The y-axis shows cumulative event rate percentage, while the x-axis shows days from randomization. Xarelto's curve shows a lower event rate than Aspirin's. The chart includes numbers of subjects at risk for each treatment group over time and a hazard ratio with confidence interval.*

FDA Label Image

Figure 10 (Xarelto 11)

A forest plot chart comparing the primary efficacy outcomes of Xarelto plus aspirin versus aspirin alone in various patient subgroups, including age, sex, region, weight, kidney function (eGFR), myocardial infarction history, stroke history, prior heart failure, diabetes, coronary artery disease (CAD), and peripheral artery disease (PAD). The horizontal axis shows hazard ratios with confidence intervals, indicating whether outcomes favor Xarelto or aspirin.*

FDA Label Image

Figure 11 (Xarelto 12)

A line graph comparing the cumulative probability (%) of an event over time in days from randomization for two groups: Xarelto plus aspirin versus aspirin alone. The graph includes a hazard ratio comparison (0.76 with 95% confidence interval 0.66 to 0.86) indicating the relative risk between the two treatments. The number of subjects at risk at various time points is displayed below the x-axis for both groups.*

* 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.