Rivaroxaban Tablet, Film Coated
Product Images NDC 72865-321

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 72865-321). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare Pharmaceuticals, Inc., 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 3 (186d9028 88fd 4703 804c 2e3c98a5b007 02)

This text provides population descriptions with PK fold change and 90% CI for various conditions such as End-Stage Renal Disease, Renal Impairment, Age, Body Weight, and Hepatic Impairment. It includes information about different groups like ESRD subjects on hemodialysis, those with different levels of renal impairment, age groups, body weight categories, and hepatic impairment severity. The text gives an overview of the relative changes compared to reference in these populations.*

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Image (186d9028 88fd 4703 804c 2e3c98a5b007 03)

This is a list showing the interaction of different drugs with P-gp and CYP3A4 inhibitors and inducers. It provides information on the fold change in pharmacokinetics such as Cmax and AUC along with their 90% confidence intervals. The drugs include ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, rifampicin, aspirin, atorvastatin, clopidogrel, digoxin, enoxaparin, maalox, midazolam, naproxen, omeprazole, ranitidine, and warfarin.*

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Fig 9 (186d9028 88fd 4703 804c 2e3c98a5b007 04)

This text provides a detailed analysis of the efficacy outcomes of Rivaroxaban compared to Placebo in various subgroups based on age, sex, region, weight, eGFR, medical history, and baseline conditions such as diabetes and prior heart failure. The results show the impact on primary efficacy outcomes such as stroke, myocardial infarction, and death. The data includes percentages and hazard ratios for different subgroups within the study, indicating where Rivaroxaban may be more favorable compared to the Placebo.*

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Figure 10 (186d9028 88fd 4703 804c 2e3c98a5b007 05)

This is a comparison of the cumulative incidence rate (%) of Rivaroxaban versus Placebo over a span of days from randomization. The data includes the number of subjects at risk for each treatment group at various intervals, providing insights into the effectiveness of Rivaroxaban.*

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Figure 11 (186d9028 88fd 4703 804c 2e3c98a5b007 06)

This is a table displaying data related to a clinical trial comparing the effects of Rivaroxaban and Placebo on a Treatment Group. The table includes the Hazard Ratio with confidence intervals, along with the number of subjects at risk at different time points from randomization. This data can be used for evaluating the effectiveness of Rivaroxaban compared to Placebo over time.*

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Figure 12 (186d9028 88fd 4703 804c 2e3c98a5b007 07)

This dataset displays the primary efficacy outcomes along with demographic and medical information related to a study. Information such as sex distribution, weight categories, history of diabetes, critical limb ischemia status, and the use of medications like Rivaroxaban and Placebo are included. The study also evaluates outcomes based on factors like age, renal function, and prior revascularization history. There are percentages and statistics provided for different variables in the study which may help in understanding the findings and conclusions of the research.*

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2.5-180s Counts (2.5 180s Counts)

This is a description of a medication called Rivaroxaban Tablets, USP, which contains 2.5mg of rivaroxaban per tablet. The usual dosage and storage information are provided, including storing the tablets at a room temperature range of 20°C to 25°C (68°F to 77°F). The medication guide should be dispensed to each patient, and the manufacturer is Ascent Pharmaceuticals, Inc., located in Central Islip, NY. The tablets are manufactured for XLCare Pharmaceuticals, Inc., based in Lawrenceville, GA.*

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2.5-60s Counts (2.5 60s Counts)

This is information related to the usual dosage and storage instructions for a medication called Rivaroxaban, with each tablet containing 2.5 mg of the active ingredient. It is important to keep the medication at room temperature within the specified range, and away from children. The text mentions a medication guide and the manufacturing company's details. For full prescribing information, it is recommended to refer to the package insert.*

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Structural Formula (Structural Formula)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.