Xarelto Tablet, Film Coated
Product Images NDC 50090-3625

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Xarelto (NDC 50090-3625). 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 (Lbl500903625)

Xarelto 10 mg film-coated tablets by A-S Medication Solutions. The label shows the proprietary name Xarelto, the generic name rivaroxaban, strength 10 mg, oral tablets, and a package count of 90 tablets. Storage instructions indicate to keep at 77 degrees Fahrenheit or room temperature. The label includes NDC 50090-3625 and a QR code for dosage information.*

FDA Label Image

Figure 1 (Xarelto 01)

A forest plot comparing hazard ratios and 95% confidence intervals for rivaroxaban versus warfarin across multiple patient subgroups, including prior warfarin use, age, gender, weight, prior stroke/TIA, diabetic status, CHADS2 score, kidney function, geographic region, and aspirin use at randomization. The plot visually indicates which treatment is favored in each subgroup based on hazard ratios centered around 1.0.*

FDA Label Image

Figure 2 (Xarelto 02)

A forest plot chart comparing major modified ISTH bleeding rates between Xarelto plus aspirin and aspirin alone across various subgroups including age, sex, region, weight, eGFR, MI history, stroke history, heart failure, diabetes, CAD, and PAD. The chart displays hazard ratios with 95% confidence intervals and sample sizes for each subgroup, showing the relative risk favoring either Xarelto or aspirin.*

FDA Label Image

Chemical Structure (Xarelto 03)

Chemical structure of rivaroxaban, the active ingredient in Xarelto 10 mg film-coated tablets by A-S Medication Solutions.*

FDA Label Image

Figure 3 (Xarelto 04)

A pharmacokinetic (PK) chart showing fold change and 90% confidence intervals for rivaroxaban under different population conditions, including end-stage renal disease, renal impairment, age, body weight, and hepatic impairment. Data compare Cmax and AUC levels relative to reference values, illustrating drug exposure variations across these groups.*

FDA Label Image

Figure 4 (Xarelto 05)

A pharmacokinetic (PK) chart showing fold change and 90% confidence intervals (CI) for various interacting drugs relative to rivaroxaban alone. It categorizes drugs into combined P-gp and strong CYP3A inhibitors, moderate inhibitors/inducers, and other drugs, displaying their effects on Cmax and AUC values.*

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Figure 5 (Xarelto 06)

A line graph comparing cumulative event rates (%) over days from randomization between Xarelto and Warfarin. The horizontal axis represents days up to 900, and the vertical axis shows cumulative event rates from 0 to 6%. Solid and dashed lines represent Xarelto and Warfarin, respectively, with number of subjects at risk and hazard ratio details also included.*

FDA Label Image

Figure 6 (Xarelto 07)

A data table comparing clinical outcomes between rivaroxaban and warfarin across various patient subgroups. It includes event counts and percentages per year, categorized by prior warfarin use, age, gender, weight, stroke history, diabetic status, CHADS2 score, creatinine clearance, geographic region, and ASA use at randomization. Accompanying the table is a hazard ratio plot with 95% confidence intervals showing comparative risk favoring rivaroxaban or warfarin.*

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Figure 7 (Xarelto 08)

A line graph comparing cumulative event rates (%) over days from randomization (0 to 360 days) between two treatments: Xarelto and Enoxaparin/VKA. The graph includes patient numbers at risk at various time points and a hazard ratio (HR) with confidence interval (CI) noted on the chart.*

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Figure 8 (Xarelto 09)

A cumulative event rate line graph comparing Enoxaparin/VKA and Xarelto over 360 days from randomization. The vertical axis shows cumulative event rate in percentage, while the horizontal axis shows days. A table below lists the number of patients at risk for both groups at various time points.*

FDA Label Image

Figure 9 (Xarelto 10)

A line graph comparing the cumulative event rates over 367 days from randomization between Xarelto and Aspirin. The Xarelto group shows a lower event rate than the Aspirin group, with data on subjects at risk presented below the x-axis. A hazard ratio with 95% confidence interval is displayed in the bottom right corner.*

FDA Label Image

Figure 10 (Xarelto 11)

A forest plot chart comparing primary efficacy outcomes between Xarelto (rivaroxaban) plus aspirin versus aspirin alone. The chart presents hazard ratios (HR) with 95% confidence intervals (CI) across various subgroups including age, sex, region, weight, eGFR, myocardial infarction history, stroke history, heart failure history, diabetes status, coronary artery disease, and peripheral artery disease. The plot visually indicates the comparative effectiveness of treatments in each subgroup.*

FDA Label Image

Figure 11 (Xarelto 12)

A cumulative probability line graph comparing Xarelto + Aspirin versus Aspirin alone over approximately 1095 days. The x-axis shows days from randomization, and the y-axis shows cumulative probability in percentage. Two lines represent Xarelto + Aspirin (solid) and Aspirin (dashed). Below the x-axis are numbers of subjects at risk for both groups at different time points. A hazard ratio of 0.76 (95% CI 0.66-0.86) is indicated for Xarelto + 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.