Xarelto Tablet, Film Coated
Product Images NDC 50090-3639

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Xarelto (NDC 50090-3639). 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 (Lbl500903639)

XARELTO 20 mg film-coated tablets label from A-S Medication Solutions. The label indicates the generic name rivaroxaban, storage instructions to store at 77 degrees Fahrenheit or room temperature, and package size of 90 tablets. The label includes product and NDC numbers and a QR code for dosage and package insert information.*

FDA Label Image

Figure 1 (Xarelto 01)

A forest plot comparing hazard ratios and 95% confidence intervals for rivaroxaban versus warfarin across various patient subgroups. The chart includes subgroup categories such as age, gender, weight, prior stroke, diabetic status, CHADS2 score, renal function (CrCl), geographic region, and aspirin use at randomization, with a central axis indicating favor towards rivaroxaban or warfarin.*

FDA Label Image

Figure 2 (Xarelto 02)

A forest plot chart showing major bleeding risk comparison between XARELTO plus aspirin and aspirin alone across various patient subgroups. Subgroups analyzed include age, sex, region, weight, eGFR, myocardial infarction history, stroke history, heart failure history, diabetes status, coronary artery disease, and peripheral artery disease. Hazard ratios (HR) with 95% confidence intervals are displayed, indicating relative risk favoring either treatment.*

FDA Label Image

Chemical Structure (Xarelto 03)

Chemical structure of rivaroxaban, the active ingredient in XARELTO 20 mg film-coated tablets by A-S Medication Solutions. The structure depicts the specific molecular arrangement of rivaroxaban.*

FDA Label Image

Figure 3 (Xarelto 04)

A pharmacokinetic (PK) chart showing fold change and 90% confidence intervals for rivaroxaban across various populations including end-stage renal disease, renal impairment (severe, moderate, mild), different age groups, body weight categories, and hepatic impairment. The chart compares Cmax and AUC values relative to a reference group, with population-specific data indicated by triangles and squares along a horizontal scale of fold change.*

FDA Label Image

Figure 4 (Xarelto 05)

A forest plot chart showing the fold change and 90% confidence intervals in pharmacokinetic parameters (Cmax, AUC) of rivaroxaban when co-administered with various interacting drugs, including combined P-gp and strong CYP3A inhibitors, moderate CYP3A inhibitors, P-gp and strong CYP3A inducers, and other drugs such as aspirin, atorvastatin, and warfarin. The x-axis represents the change relative to rivaroxaban alone.*

FDA Label Image

Figure 5 (Xarelto 06)

A line chart showing cumulative event rates (%) over days from randomization (0 to 900 days) comparing XARELTO and Warfarin. Two cumulative event rate lines are plotted, one solid (XARELTO) and one dashed (Warfarin). The graph includes number of subjects at risk at multiple time points for each treatment.*

FDA Label Image

Figure 6 (Xarelto 07)

A data table comparing event rates per year (%) between rivaroxaban and warfarin across various patient subgroups, including age, gender, weight, prior stroke, diabetic status, and kidney function, accompanied by a hazard ratio forest plot showing the relative risk with 95% confidence intervals favoring either rivaroxaban or warfarin.*

FDA Label Image

Figure 7 (Xarelto 08)

A line graph comparing cumulative event rates (%) between Enoxaparin/VKA and XARELTO over 360 days from randomization. The x-axis shows days, and the y-axis shows cumulative event rate. The graph includes patient risk numbers at various time points and a hazard ratio with confidence interval. XARELTO shows a lower cumulative event rate compared to Enoxaparin/VKA throughout the period.*

FDA Label Image

Figure 8 (Xarelto 09)

A line graph comparing the cumulative event rate (%) over time (days from randomization) for XARELTO (rivaroxaban) and Enoxaparin/VKA. The x-axis represents days from 0 to 360, and the y-axis shows the cumulative event rate from 0 to 4%. The graph includes patient numbers at risk for both treatments at various time points and a hazard ratio (HR) with 95% confidence interval.*

FDA Label Image

Figure 9 (Xarelto 10)

A line graph comparing cumulative event rates (%) over 367 days from randomization for XARELTO and Aspirin. The XARELTO line shows a lower event rate compared to Aspirin over time. Below the graph, the number of subjects at risk for each treatment is listed at various time points. A hazard ratio with 95% confidence interval is displayed in the bottom right corner.*

FDA Label Image

Figure 10 (Xarelto 11)

A forest plot comparing outcomes between XARELTO plus aspirin and aspirin alone across various subgroups, including age, sex, region, weight, eGFR, MI history, stroke history, heart failure history, diabetes status, and cardiovascular conditions. The plot shows hazard ratios (HR) with 95% confidence intervals (CI) and visual markers indicating favorability towards XARELTO or aspirin.*

FDA Label Image

Figure 11 (Xarelto 12)

A cumulative probability line graph comparing XARELTO plus Aspirin versus Aspirin alone over approximately three years (up to 1095 days). The x-axis shows days from randomization, and the y-axis shows cumulative probability percentage. The solid line represents XARELTO plus Aspirin, and the dashed line represents Aspirin alone. The graph includes numbers of subjects at risk at multiple time points and a hazard ratio with 95% confidence interval for XARELTO plus Aspirin versus Aspirin.*

* 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.