Xarelto Tablet, Film Coated
Product Images NDC 55154-1423

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Xarelto (NDC 55154-1423). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cardinal Health 107, Llc, 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

Ce538950 C1cf 4b9b 9434 A4b96c1d461e 00

Xarelto 20 mg tablets label showing the product name, active ingredient rivaroxaban, strength 20 mg, and dispensation instructions. The label includes warnings to keep out of reach of children, storage instructions, manufacturer details (Bayer Pharmaceuticals AG), and distributor information (Cardinal Health 107, LLC). A barcode is also visible on the label.*

FDA Label Image

Ce538950 C1cf 4b9b 9434 A4b96c1d461e 01

Xarelto 15 mg tablets label by Cardinal Health 107, LLC displays information for approximately 2070 tablets. It specifies each tablet contains 15 mg rivaroxaban, includes storage instructions (59-86°F), warnings to keep out of reach of children, and directions to dispense the Medication Guide to each patient. The label includes lot number, expiration date, and barcodes.*

FDA Label Image

Ce538950 C1cf 4b9b 9434 A4b96c1d461e 02

Xarelto 10 mg tablets packaging label showing a 10-tablet unit dose. The active ingredient is rivaroxaban. The label includes storage instructions, a warning that the package is not child resistant and intended for hospital use, and manufacturing and distribution details for Cardinal Health and Janssen Pharmaceuticals.*

FDA Label Image

Figure 1 (Xarelto 01)

A forest plot chart comparing hazard ratios and 95% confidence intervals for Rivaroxaban versus Warfarin across various patient subgroups and factors, including prior Warfarin usage, age, gender, weight, prior stroke/TIA, diabetes status, CHADS2 score, creatinine clearance, geographic region, and aspirin administration. The horizontal axis ranges from 0.5 to 2, indicating relative risk, with subgroup-specific data points and confidence intervals shown for each drug.*

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Chemical Structure (Xarelto 02)

Chemical structure diagram showing the molecular formula of the active ingredient in Xarelto, an anticoagulant medication. The structure includes multiple rings and a chlorine-substituted thiophene moiety.*

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Figure 2 (Xarelto 03)

A pharmacokinetic (PK) chart showing fold change and 90% confidence intervals (CI) in drug concentration parameters Cmax and AUC compared to reference values for Xarelto. It details the effects of population factors including end-stage renal disease, varying degrees of renal impairment, age groups, body weight categories, and hepatic impairment on these PK parameters.*

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Figure 3 (Xarelto 04)

A pharmacokinetic chart showing fold changes in Cmax and AUC with 90% confidence intervals for various interacting drugs compared to rivaroxaban alone. The drugs are grouped as combined P-gp and CYP3A inhibitors, CYP3A inducers, and other drugs, depicting their impact on rivaroxaban exposure.*

FDA Label Image

Figure 4 (Xarelto 05)

A cumulative event rate curve graph comparing Xarelto and Warfarin over days from randomization, showing two lines representing cumulative event rates (%) for both drugs. The X-axis shows days up to 900, and the Y-axis shows cumulative event rates up to 6%. The graph also includes numbers of subjects at risk over time for each drug and a hazard ratio (HR) with confidence interval (CI).*

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Figure 5 (Xarelto 06)

A forest plot comparing hazard ratios (HR) and 95% confidence intervals (CIs) for Rivaroxaban versus Warfarin across various patient subgroups, including age, gender, weight, prior stroke/TIA, presence of diabetes or heart failure, CHA2DS2 score, renal function, geographic region, ACS at randomization, and others. The plot visually displays HRs alongside numerical data of event rates per year for each group, illustrating comparative treatment effects.*

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Figure 6 (Xarelto 07)

A line graph comparing the cumulative event rate (%) over time (days from randomization) between Enoxaparin/VKA and Xarelto. The X-axis represents days from randomization up to 360 days, and the Y-axis shows cumulative event rate percentage, ranging from 0.0 to 4.0%. The graph includes a hazard ratio (HR) with 95% confidence interval (CI) values, and a table below the X-axis indicates the number of patients at risk over time for both treatments.*

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Figure 7 (Xarelto 08)

A cumulative event rate chart comparing Xarelto and Enoxaparin/VKA over 360 days from randomization. The y-axis shows cumulative event rate percentage, and the x-axis shows days from randomization. A hazard ratio with 95% confidence interval is included, along with a table of patients at risk over time for both treatments.*

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Figure 8 (Xarelto 09)

A cumulative event rate line graph comparing Xarelto and Aspirin over 367 days from randomization, showing the cumulative event percentage on the y-axis and days on the x-axis. It includes a hazard ratio of 0.26 (95% CI 0.14 to 0.47) and the number of subjects at risk at multiple time points for both drugs.*

FDA Label Image

Xarelto 10

A forest plot displaying the primary efficacy outcomes of Xarelto versus placebo for composite endpoints including stroke, myocardial infarction, or cardiovascular death. The chart presents hazard ratios with 95% confidence intervals across various subgroups such as age, sex, region, weight, kidney function, medical history, and comorbidities, illustrating comparative risk assessments between treatments.*

FDA Label Image

Xarelto 11

This is a line graph displaying the cumulative incidence rate (%) over days from randomization for Xarelto compared with placebo. The x-axis shows days ranging from 0 to 1095, and the y-axis shows cumulative incidence rate from 0 to 10%. Two lines represent Xarelto (solid) and placebo (dashed), with Xarelto showing consistently lower incidence. A hazard ratio of 0.74 (95% CI: 0.65-0.86) is noted for Xarelto vs placebo. The number of subjects at risk for both groups is listed below the x-axis at multiple time points.*

FDA Label Image

Xarelto 12

A line graph showing the cumulative incidence rate (%) on the Y-axis versus days from randomization on the X-axis, comparing Xarelto and placebo treatment groups. The solid line represents Xarelto, and the dashed line represents placebo. The graph includes a table of subjects at risk below the X-axis and a hazard ratio comparison for Xarelto versus placebo.*

FDA Label Image

Xarelto 13

A forest plot comparing the primary efficacy outcomes between Xarelto and placebo across various subgroups, including age, sex, weight, eGFR, baseline diabetes, CAD, clopidogrel use, history of revascularization, and critical limb ischemia categories. The plot shows hazard ratios with 95% confidence intervals, illustrating the relative risk between Xarelto and placebo for each subgroup.*

* 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.