Xarelto Tablet, Film Coated
Product Images NDC 50090-4469

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Xarelto (NDC 50090-4469). 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 (Lbl500904469)

Label for Xarelto 10 mg film-coated tablets, an oral human prescription drug containing rivaroxaban, manufactured by A-S Medication Solutions. The label states each tablet contains 10 mg of rivaroxaban and the package contains 90 tablets. Storage instructions recommend room temperature. The label also includes the product and NDC numbers along with a dosage instruction QR code.*

FDA Label Image

Figure 1 (Xarelto 01)

A forest plot comparing hazard ratios and 95% confidence intervals between Rivaroxaban and Warfarin across multiple patient subgroups, including prior Warfarin/VKA use, age categories, gender, weight, prior stroke/TIA, diabetic status, CHADS2 score, creatinine clearance, geographic region, and aspirin use at randomization. The plot visualizes favoring either Rivaroxaban or Warfarin with markers and horizontal lines representing confidence intervals, along with corresponding numerical hazard ratios and confidence intervals to the right.*

FDA Label Image

Figure 2 (Xarelto 02)

A forest plot chart comparing the incidence of major bleeding events according to ISTH criteria between Xarelto plus aspirin and aspirin alone. The chart breaks down data by age, sex, region, weight, eGFR, MI history, stroke history, heart failure, diabetes, CAD, and PAD, showing hazard ratios with 95% confidence intervals for each subgroup.*

FDA Label Image

Chemical Structure (Xarelto 03)

Chemical structure of rivaroxaban, the active ingredient in Xarelto 10 mg oral film-coated tablets by A-S Medication Solutions. The diagram shows the molecular structure with rings and functional groups characteristic of rivaroxaban.*

FDA Label Image

Figure 3 (Xarelto 04)

A chart depicting pharmacokinetic (PK) fold change and 90% confidence intervals for rivaroxaban in various population groups, including end-stage renal disease, renal impairment, age, body weight, and hepatic impairment. The chart compares Cmax and AUC values relative to a reference, illustrating exposure changes across these conditions.*

FDA Label Image

Figure 4 (Xarelto 05)

A pharmacokinetic chart showing the fold change and 90% confidence intervals in Cmax and AUC of various interacting drugs relative to rivaroxaban alone. The chart categorizes interacting drugs by their mechanism, including combined P-gp and strong or moderate CYP3A inhibitors and inducers, and other drugs. It visually presents changes in drug exposure for agents like ketoconazole, ritonavir, erythromycin, and rifampicin, among others.*

FDA Label Image

Figure 5 (Xarelto 06)

A line graph comparing cumulative event rates (%) over time (days from randomization) for two drugs: Xarelto and Warfarin. The solid line represents Xarelto and the dashed line Warfarin. The graph includes a hazard ratio (HR) with 95% confidence interval (CI) at 0.88 (0.74, 1.03). The number of subjects at risk for each drug is indicated below the x-axis at various time points up to 900 days.*

FDA Label Image

Figure 6 (Xarelto 07)

A forest plot displaying hazard ratios and 95% confidence intervals comparing rivaroxaban and warfarin across various patient subgroups. The graph shows favorability ranges on the x-axis with data points indicating hazard ratios for groups such as age, gender, weight, prior stroke, diabetic status, kidney function, geographic region, and ASA use at randomization, illustrating relative risk metrics between the two treatments.*

FDA Label Image

Figure 7 (Xarelto 08)

A Kaplan-Meier cumulative event rate curve comparing Xarelto (rivaroxaban) and Enoxaparin/VKA over days from randomization up to 360 days. The Y-axis shows cumulative event rate percentage. The chart includes patient numbers at risk over time for each treatment group below the X-axis and a hazard ratio (HR) with 95% confidence interval (CI) noted in the graph.*

FDA Label Image

Figure 8 (Xarelto 09)

A cumulative event rate graph comparing Enoxaparin/VKA and Xarelto with respect to days from randomization over a 360-day period. The y-axis shows the cumulative event rate in percentage, and the x-axis shows days from randomization. The number of patients at risk at multiple time points is listed below the graph for both treatments, with hazard ratio and confidence interval noted on the image.*

FDA Label Image

Figure 9 (Xarelto 10)

A Kaplan-Meier curve comparing cumulative event rates (%) over 367 days from randomization for Xarelto versus Aspirin. The solid line represents Xarelto, and the dashed line represents Aspirin, showing lower cumulative events in Xarelto. Below the graph, the number of subjects at risk for each group is listed at different time points. The hazard ratio with 95% confidence interval is displayed in the bottom right.*

FDA Label Image

Figure 10 (Xarelto 11)

A forest plot comparing the primary efficacy outcome of Xarelto (rivaroxaban) plus aspirin versus aspirin alone across various subgroups such as age, sex, region, weight, eGFR, MI history, stroke history, heart failure history, baseline diabetes, CAD, PAD, and combined CAD with PAD. The plot shows hazard ratios (HR) with 95% confidence intervals (CI), indicating the relative effect of treatments for each subgroup.*

FDA Label Image

Figure 11 (Xarelto 12)

A cumulative probability line graph comparing Xarelto plus Aspirin versus Aspirin alone over time in days from randomization, with probability percentage on the y-axis and days on the x-axis. The graph includes a hazard ratio of 0.76 (95% CI 0.66-0.86) for Xarelto plus Aspirin versus Aspirin, as well as subject counts at risk at various time points.*

* 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.