Xarelto Tablet, Film Coated
Product Images NDC 71610-690

Product Visual Gallery

This gallery contains 35 technical images submitted to the FDA as part of the official labeling for Xarelto (NDC 71610-690). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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.

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Bottle Label 10 mg (71610 0690 42)

Xarelto (rivaroaban) 10 mg film-coated tablets packaging label showing 1800 tablets and NDC 71610-0690-42. The label includes storage instructions, warnings, manufacturer Janssen Ohio, LLC, and repackager Aphena Pharma Solutions - Tennessee, LLC. The label also displays lot number, manufacture, and expiration dates.*

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Aphena Pharma Solutions (TN)

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Figure 1 (Xarelto 01)

A forest plot chart comparing hazard ratios and 95% confidence intervals between rivaroxaban and warfarin across various patient subgroups and conditions. The chart presents data such as prior Warfarin/VKA use, age, gender, weight, diabetic status, CHADS2 score, kidney function levels, geographic region, and ASA randomization status, showing points and lines indicating hazard ratios favoring either rivaroxaban or warfarin along a horizontal axis scaled from 0.5 to 2.*

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Chemical Structure (Xarelto 02)

Chemical structure of rivaroxaban, the active ingredient in Xarelto. The diagram shows the molecular framework including rings, bonds, and functional groups characteristic of rivaroxaban's chemical composition.*

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Figure 2 (Xarelto 03)

A pharmacokinetic fold change chart depicting Cmax and AUC values with 90% confidence intervals for various populations relative to reference. Populations include end-stage renal disease, varying degrees of renal impairment, age groups, body weight categories, and hepatic impairment, showing the drug's pharmacokinetic variability under these conditions.*

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Figure 3 (Xarelto 04)

A chart illustrating the pharmacokinetic interactions of various drugs when co-administered with rivaroxaban. The graph shows fold changes and 90% confidence intervals for Cmax and AUC values of interacting drugs categorized by inhibitor or inducer type, such as combined P-gp and CYP3A inhibitors, moderate CYP3A inhibitors, and other drugs, with changes relative to rivaroxaban alone plotted on a horizontal axis.*

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Figure 4 (Xarelto 05)

A line graph comparing cumulative event rates (%) over time (days from randomization) for Xarelto and Warfarin. Xarelto is represented by a solid line and Warfarin by a dashed line. The graph includes a table of the number of subjects at risk at various time points and displays the hazard ratio with confidence interval (HR 0.88, 95% CI 0.74 to 1.03) on the graph.*

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Figure 5 (Xarelto 06)

A forest plot comparing hazard ratios and 95% confidence intervals for Rivaroxaban versus Warfarin across various patient subgroups. The chart includes data stratified by factors such as prior Warfarin/VKA use, age, gender, weight, prior stroke/TIA, diabetic status, CHADS2 score, creatinine clearance, geographic region, and ASA use at randomization. The hazard ratios and confidence intervals are plotted to show relative favorability toward Rivaroxaban or Warfarin.*

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Figure 6 (Xarelto 07)

A Kaplan-Meier cumulative event rate graph comparing Xarelto (rivaroxaban) and Enoxaparin/VKA over 360 days from randomization. The y-axis shows cumulative event rate (%) and the x-axis shows days from randomization. The chart includes numbers of patients at risk over time for each group and hazard ratio with confidence interval.*

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Figure 7 (Xarelto 08)

A line graph showing cumulative event rates over 360 days from randomization comparing Xarelto (rivaroxaban) with Enoxaparin/VKA. The y-axis represents the cumulative event rate (%) and the x-axis shows days from randomization. Two lines depict event rates for each treatment, with patient risk numbers listed below.*

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Figure 8 (Xarelto 09)

A cumulative event rate graph comparing Xarelto and Aspirin over 367 days from randomization. The x-axis represents days, while the y-axis shows cumulative event rate percentage. The chart includes subject counts at risk for both groups and a hazard ratio with confidence interval for Xarelto relative to Aspirin.*

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Figure 9 (Xarelto 10)

A forest plot chart illustrating the primary efficacy outcome comparing Xarelto (rivaroxaban) versus placebo across various subgroups including age, sex, region, weight, kidney function (eGFR), myocardial infarction history, stroke history, heart failure history, baseline diabetes, and peripheral artery disease (PAD). The chart displays hazard ratios (HR) with 95% confidence intervals, showing effect estimates and confidence intervals for each subgroup, and indicates whether results favor Xarelto or placebo.*

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Figure 10 (Xarelto 11)

A Kaplan-Meier cumulative incidence rate chart showing the incidence over days from randomization for Xarelto (rivaroxaban) compared to placebo. The y-axis represents cumulative incidence rate (%) up to 10%, and the x-axis shows time in days up to 1095 (3 years). The graph includes the number of subjects at risk in each group across multiple time points and a hazard ratio comparison between Xarelto and placebo.*

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Figure 11 (Xarelto 12)

A line chart showing cumulative incidence rate (%) over days from randomization for two treatment groups: Xarelto and placebo. The chart includes a legend and a table of the number of subjects at risk over time. The plot compares the cumulative incidence rate between Xarelto (solid line) and placebo (dashed line) groups, with a hazard ratio of 0.85 (95% CI: 0.76, 0.96) indicated.*

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Figure 12 (Xarelto 13)

A forest plot comparing Xarelto (rivaroxaban) versus placebo on primary efficacy outcomes across multiple patient subgroups. The plot displays hazard ratios (HR) with 95% confidence intervals by age, sex, weight, eGFR, diabetes, coronary artery disease, randomization strata, clopidogrel use, history of revascularization, and critical limb ischemia categories, showing comparative effectiveness of Xarelto relative to placebo.*

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Image (Xarelto 14)

Illustration of a cylindrical medical device resembling a syringe or dosing instrument with a vertical scale on its transparent section. The scale is color-coded with multiple horizontal bands in different colors, marked with numeric values presumably indicating measurements. The device has a purple casing and a white top nozzle.*

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Image (Xarelto 15)

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Image (Xarelto 16)

An illustration of a purple oral syringe with graduations from 0.5 mL to 5 mL marked in black. The syringe is designed to measure liquid medication doses precisely.*

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Image (Xarelto 17)

Illustration of a purple syringe with labeled parts: the tip at the top and the plunger at the bottom. The syringe barrel includes color-coded measurement markings along its length for volume, ranging from 0.3 to 3 mL.*

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Image (Xarelto 18)

An instructional diagram showing a brown glass bottle with a white plastic cap separated above it. The diagram labels the cap and the bottle adaptor attached to the neck of the bottle, with a caution not to remove the bottle adaptor. This image is related to packaging or usage instructions for a liquid medication container.*

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Image (Xarelto 19)

An illustration showing a medication bottle with a label area highlighted, indicating where to check the "Discard after" date. The image serves as an instructional guide on locating the discard date on the bottle's label.*

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Image (Xarelto 20)

An instructional illustration showing two hands being washed with water flowing from a faucet. Water droplets are depicted in blue to indicate rinsing. The image emphasizes handwashing technique.*

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Image (Xarelto 21)

An instructional illustration showing a hand holding and shaking a bottle slowly. The word 'SLOW!' is displayed in blue text above the hand. This image likely provides guidance related to handling medication bottles or liquid products.*

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Image (Xarelto 22)

An instructional illustration showing a close-up view of a tablet bottle being inspected with a focus circle and checkmark, indicating correct verification or inspection of the bottle's contents or label.*

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Image (Xarelto 23)

An illustration of a graduated oral syringe marked with volume measurements from 0.8 mL to 3 mL, with a 5 mL total capacity indicated. Color-coded segments correspond to various volume markings along the syringe barrel. The device is designed for precise oral liquid dosing.*

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Image (Xarelto 24)

Table listing volume dose measurements, showing breakdowns of 7.5 mL, 10 mL, 15 mL, and 20 mL doses into combinations of 5 mL increments.*

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Image (Xarelto 25)

Illustration showing a hand holding a syringe with the plunger being pressed down, indicated by a blue arrow. An inset magnifies the tip of the syringe, highlighting the needle and cap area. This instructional diagram focuses on proper syringe use and handling.*

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Image (Xarelto 26)

An instructional illustration showing a hand holding a bottle and another hand inserting a bottle adaptor down into the bottle's opening, with an open bottle cap placed to the side. The image depicts how to attach the bottle adaptor to the bottle.*

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Image (Xarelto 27)

Illustration showing a hand holding a syringe vertically with a plunger being pressed down, indicated by a blue downward arrow. The image appears to demonstrate the proper technique for administering or preparing an injectable medication, though it is not related to Xarelto tablets.*

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Image (Xarelto 28)

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Image (Xarelto 29)

Illustration showing hands assembling or using a medical device component, with a close-up inset highlighting small particles or bubbles inside a container or tube, likely demonstrating a preparation or usage step.*

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Image (Xarelto 30)

An instructional illustration showing a person holding a syringe with one hand while the other hand stabilizes the plunger. A blue arrow points upward, indicating the direction to pull or push the plunger.*

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Image (Xarelto 31)

An instructional illustration showing a hand holding a bottle while another hand inserts a dropper or dosing device into the bottle. A blue arrow points upward from the dropper, indicating an upward movement or removal. The image likely demonstrates how to use or prepare the medication dosing device with the bottle.*

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Image (Xarelto 32)

An instructional illustration showing a person administering an oral medication using a syringe, aimed at guiding proper dosage delivery into the mouth.*

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Image (Xarelto 33)

An instructional illustration showing a hand holding a narrow tube or test strip and another hand holding a small dropper bottle under a showerhead with water droplets falling. It depicts rinsing or washing of the tube or instrument under running water.*

* 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.