Rivaroxaban Tablet, Film Coated
Product Images NDC 31722-496

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 31722-496). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber 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 appears to provide a description of Population Pharmacokinetics (PK) Fold Change and 90% Confidence Interval (CI) related to various demographics and health conditions such as End-Stage Renal Disease, Renal Impairment, Age, Body Weight, and Hepatic Impairment. It includes data on changes relative to a reference group across different parameters. The information appears to be detailed and specific to the conditions and factors mentioned.*

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

This is a list detailing the pharmacokinetic fold change and 90% confidence interval when certain drugs are combined with strong or moderate CYP3A4 inhibitors or inducers. The text also mentions the interaction of other drugs like aspirin, atorvastatin, clopidogrel, digoxin, enoxaparin, and omeprazole. The impact on drug absorption and blood concentration levels is highlighted for each combination.*

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

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

This text provides data on the cumulative incidence rate (%) of subjects receiving Rivaroxaban versus Placebo over a period of days from randomization. The number of subjects at risk for each treatment group is also shown at various time points. Rivaroxaban appears to show a lower incidence rate compared to Placebo based on the provided statistics.*

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

This document appears to present data from a clinical trial comparing the efficacy of Rivaroxaban versus Placebo in a treatment group. The table includes information on the hazard ratio (with a 95% confidence interval) between Rivaroxaban and Placebo, and a timeline with the number of subjects at risk over various days from randomization. It seems to be a clinical study evaluating the impact of these treatment options over time.*

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

This text appears to show data related to a medical study or clinical trial. It includes information on efficacy outcomes, gender distribution, weight categories, baseline characteristics such as diabetes and chronic artery disease, randomization details, and data related to the use of medications like Clopidogrel and Rivarozaban. The text also presents statistics such as the number of participants in each group and the outcomes observed. This data could be used to analyze the effects of different factors on the study's results.*

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2.5-180s Counts (2.5 180s Counts)

This text provides information about Rivaroxaban tablets, containing 2.5 mg of Rivaroxaban, USP. It includes instructions to dispense the Medication Guide to each patient. The tablets are for prescription use only, and the usual dosage is detailed in the package insert. It also mentions storage instructions at room temperature and provides the manufacturer details for Ascent Pharmaceuticals Inc. and Camber Pharmaceuticals.*

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2.5-60s Counts (2.5 60s Counts)

This is a description for Rivaroxaban Tablets, USP. Each tablet contains 2.5 mg of rivaroxaban and there are 60 tablets in the package. The usual dosage instructions are provided in the package insert. The medication should be stored at room temperature between 20°C to 25°C with excursions permitted between 15°C to 30°C. The medication guide is available online and should be dispensed to each patient. The tablets are for prescription use only and should be kept out of reach of children. The tablets are manufactured by Ascent Pharmaceuticals Inc. and distributed by Camber Pharmaceuticals, Inc. *

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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.