Rivaroxaban Tablet, Film Coated
Product Images NDC 55488-0540

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Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 55488-0540). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Changzhou Pharmaceutical Factory, 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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Chemical Structure (Chemical Structure)

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Figure 1 (Figure 01)

Figure 1 (Figure 01)
This is a detailed statistical data table outlining patient demographics, medical history, treatment interventions, and outcomes related to Warfarin/VKA and Rivaroxaban usage. The table includes information on patient characteristics such as age, gender, weight, diabetic status, CHADSâ‚‚ score, creatinine clearance levels, geographic regions, and ASA usage. Additionally, there are hazard ratios and 95% confidence intervals provided for comparison between the two treatment groups. The data is presented in a structured format, making it suitable for analysis and interpretation in a clinical or research setting.*
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Figure 2 (Figure 02)

Figure 2 (Figure 02)
This text provides descriptions of fold changes and 90% confidence intervals for various population groups based on factors such as End-Stage Renal Disease, Renal Impairment, Age, Body Weight, and Hepatic Impairment. It outlines the differences in PK parameters such as Cmax and AUC for different conditions and demographics, offering insights into how these factors affect pharmacokinetics. Additionally, it includes specific details about ESRD subjects, creatinine clearance levels, and reference comparisons.*
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Figure 3 (Figure 03)

Figure 3 (Figure 03)
This is a list of drug interactions showing the PK fold change and 90% confidence interval when combined with various inhibitors and inducers of P-gp and CYP3A enzymes. It includes drugs like Ketoconazole, Ritonavir, Erythromycin, Rifampicin, Fluconazole, and others, along with their effects on parameters like AUC and Cmax. The table also mentions the relative change compared to Rivaroxaban alone.*
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Figure 4 (Figure 04)

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Figure 5 (Figure 05)

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Figure 6 (Figure 06)

Figure 6 (Figure 06)
This text provides data on the cumulative event rate (%) and the number of patients at risk for different treatment groups over days from randomization, as well as the hazard ratio with a 95% confidence interval. The comparison is between Enoxaparin/VKA and Rivaroxaban treatments.*
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Figure 7 (Figure 07)

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Figure 8 (Figure 08)

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Figure 9 (Figure 09)

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Figure 10 (Figure 10)

Figure 10 (Figure 10)
This is a comparison of the cumulative incidence rate (%) between Rivaroxaban and Placebo treatment groups. The Hazard Ratio (95% CI) shows a value of 0.74 (0.65-0.86), suggesting a lower incidence rate with Rivaroxaban compared to Placebo. The study involved 8313 subjects receiving Rivaroxaban and 8261 subjects receiving Placebo. The data is measured over different time points in days from randomization, ranging from 180 days to 1095 days.*
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Figure 11 (Figure 11)

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Figure 12 (Figure 12)

Figure 12 (Figure 12)
This is not-readable.*
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10mg-30 Tablets (Label 01)

10mg-30 Tablets (Label 01)
Each tablet contains 10 mg of rivaroxaban. This medication is usually for adults and should be stored at room temperature, away from children. The drug is manufactured by Changzhou Pharmaceutical Factory in China and comes with a Medication Guide for patients. The usual dosage should be followed as indicated in the package insert.*
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15mg-30 Tablets (Label 04)

15mg-30 Tablets (Label 04)
This text is a pharmaceutical label for Rivaroxaban tablets. The tablets contain 15 mg of Rivaroxaban each. The usual dosage instructions are not provided, advising to refer to the package insert for full prescribing information. It also includes storage instructions, manufacturer details, and a directive to dispense the accompanying Medication Guide to each patient. The label is for a package of 30 tablets and has an NDC code of 55488-0541-1. The tablets are distributed by Changzhou Pharmaceutical Factory.*
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20mg-30 Tablets (Label 07)

20mg-30 Tablets (Label 07)
This is a description of rivaroxaban tablets, a medication used for anticoagulation therapy. Each tablet contains 20 mg of rivaroxaban. The usual dosage information can be found in the package insert. It should be stored at room temperature and kept out of reach of children. The tablets are manufactured by Changzhou Pharmaceutical Factory in China. The medication guide should be dispensed to each patient. The text also includes NDC and RX information.*

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