Rivaroxaban Tablet, Film Coated
Product Images NDC 59651-849

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 59651-849). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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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Figure 1 (Rivaroxaban Fig1)

A forest plot chart showing hazard ratios and 95% confidence intervals comparing Rivaroxaban and Warfarin across multiple patient subgroups, including age, gender, weight, prior stroke/TIA, diabetic status, CHADS2 score, creatinine clearance levels, geographic region, and ASA use at randomization. The chart visually indicates effect favoring either Rivaroxaban or Warfarin with detailed numerical hazard ratios and confidence intervals listed.*

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Figure 10 (Rivaroxaban Fig10)

A line graph showing cumulative incidence rates (%) over days from randomization comparing Rivaroxaban and Placebo in a clinical study. The graph includes a hazard ratio of 0.74 (95% CI: 0.65 to 0.86) for Rivaroxaban versus Placebo. It features a risk table indicating the number of subjects at risk at various time points up to 1095 days.*

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Figure 11 (Rivaroxaban Fig11)

A Kaplan-Meier curve showing cumulative incidence rates (%) over time in days from randomization for two treatment groups: Rivaroxaban and Placebo. The solid line represents the Rivaroxaban group, and the dashed line represents the Placebo group. The graph includes a hazard ratio comparison of 0.85 (95% CI: 0.76 to 0.96) for Rivaroxaban versus Placebo. A table below the x-axis displays the number of subjects at risk at various time points for each group.*

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Figure 12 (Rivaroxaban Fig12)

A forest plot comparing the primary efficacy outcomes between Rivaroxaban and placebo. It displays hazard ratios (HR) with 95% confidence intervals across various subgroups including age, sex, weight, eGFR, baseline diabetes, CAD, randomization strata, clopidogrel use, history of revascularization, and critical limb ischemia categories. The plot shows relative risk reductions favoring Rivaroxaban in most subgroups.*

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Package Label-principal Display Panel (2.5 mg (60 Tablets Bottle))

Rivaroxaban Tablets, USP 2.5 mg film-coated tablets, supplied in a package of 60 tablets by Aurobindo Pharma Limited. The label includes dosage information, storage instructions between 20° to 25°C, and a note to dispense the Medication Guide. Distributed by Aurobindo Pharma USA, Inc., made in India, with a barcode and coding area indicated on the label.*

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Figure 2: Effect Of Specific Adult Populations On The Pharmacokinetics Of Rivaroxaban (Rivaroxaban Fig2)

A forest plot chart depicting the fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax and AUC) of rivaroxaban across different populations, including end-stage renal disease, renal impairment severities, age groups, body weight categories, and hepatic impairment levels. The chart compares these values relative to a reference group.*

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Figure 3: Effect Of Coadministered Drugs On The Pharmacokinetics Of Rivaroxaban In Adults (Rivaroxaban Fig3)

A pharmacokinetic chart showing fold changes and 90% confidence intervals of various interacting drugs relative to Rivaroxaban alone. The x-axis represents change relative to Rivaroxaban alone, with data points for Cmax and AUC values of drugs categorized as strong/moderate CYP3A inhibitors, inducers, and other drugs, including Ketoconazole, Ritonavir, Clarithromycin, Erythromycin, Fluconazole, Rifampicin, Aspirin, Atorvastatin, Clopidogrel, Digoxin, Enoxaparin, Maalox, Midazolam, Naproxen, Omeprazole, Ranitidine, and Warfarin.*

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Figure 4 (Rivaroxaban Fig4)

A cumulative event rate graph comparing Rivaroxaban and Warfarin over days from randomization up to 900 days. The solid line represents Rivaroxaban, and the dashed line represents Warfarin. The x-axis shows days from randomization, and the y-axis shows cumulative event rates as percentages. A table below the graph lists the number of subjects at risk over time for both drugs. The hazard ratio with a 95% confidence interval is also displayed in the graph's lower right corner.*

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Figure 5 (Rivaroxaban Fig5)

A forest plot chart comparing hazard ratios and 95% confidence intervals for Rivaroxaban versus Warfarin across various patient subgroups. Variables include prior warfarin use, age, gender, weight, prior stroke/TIA, diabetic status, CHADS2 score, renal function (CrCl), geographic region, and ASA use at randomization.*

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Fig7 (Rivaroxaban Fig6)

A cumulative event rate graph comparing Rivaroxaban and Enoxaparin/VKA over 360 days from randomization. The y-axis shows cumulative event rate percentages, and the x-axis shows days. The chart includes a hazard ratio (HR) with confidence interval and patient risk numbers for both treatments at various time points.*

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Fig8 (Rivaroxaban Fig7)

A cumulative event rate (%) line graph comparing Rivaroxaban and Enoxaparin/VKA over days from randomization up to 360 days. The graph includes patient numbers at risk for both treatments at specific time points and displays a hazard ratio (HR) with 95% confidence intervals.*

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Fig8 (Rivaroxaban Fig8)

A Kaplan-Meier cumulative event rate graph comparing Rivaroxaban and Aspirin over 367 days from randomization. The y-axis shows cumulative event rate (%) and the x-axis shows days from randomization. The graph includes a hazard ratio with 95% confidence interval (0.26, 0.14 to 0.47). Number of subjects at risk per time point is listed below the x-axis for both drugs.*

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Figure 9 (Rivaroxaban Fig9)

A forest plot comparing the primary efficacy outcome (composite of stroke, myocardial infarction, or cardiovascular death) rates between Rivaroxaban and placebo groups across various subgroups including age, sex, region, weight, eGFR, myocardial infarction history, stroke history, prior heart failure, baseline diabetes, and peripheral artery disease. The plot displays hazard ratios with 95% confidence intervals and event rates, illustrating the relative risk favoring Rivaroxaban or placebo in each subgroup.*

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Chemical Structure (Rivaroxaban Str)

Chemical structure of rivaroxaban, showing its molecular composition with rings and functional groups, including a chlorothiophene moiety.*

* 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.