Rivaroxaban Tablet, Coated
Product Images NDC 51672-4228

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 51672-4228). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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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1 (Dispense With Medication Guide Available At Page 1)

Medication Guide text panel for Rivaroxaban Tablets, USP, describing risks including increased blood clot risk if stopped and increased bleeding risk. It lists medicines that may raise bleeding risk and symptoms requiring medical attention, as well as warnings about spinal or epidural blood clots.*

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2 (Dispense With Medication Guide Available At Page 2)

This image shows a text panel from a Rivaroxaban medication guide discussing key information. It includes warnings about when to tell your doctor, describing conditions like muscle weakness and loss of bowel or bladder control. The panel defines what Rivaroxaban is used for when taken with aspirin. It lists situations when Rivaroxaban should not be taken, advises on informing the doctor about medical conditions and medications, and provides instructions on how to properly take Rivaroxaban tablets as prescribed.*

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3 (Dispense With Medication Guide Available At Page 3)

This image shows part of the medication guide text for Rivaroxaban tablets 2.5 mg, including instructions about stopping the medication before surgeries, recommended dosing for heart and peripheral artery disease, storage information, possible side effects emphasis on bleeding, and inactive ingredients. It also includes distributor information for Sun Pharmaceutical Industries, Inc.*

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Container Label (Rx525660200l60 Sun19a)

Label for Rivaroxaban Tablets USP 2.5 mg coated oral tablets, containing 60 tablets per package. The label instructs dispensing with an accompanying Medication Guide and notes the product is Rx only. Manufactured by Taro Pharmaceutical Industries Ltd., distributed by Sun Pharmaceutical Industries, Inc.*

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Chemical Structure (Rivaroxaban 02)

Chemical structure of Rivaroxaban, showing its molecular framework including lactam, oxazolidinone, and thiophene moieties with a chlorine substituent.*

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Figure 2 (Rivaroxaban 03)

A fold change and 90% confidence interval chart showing pharmacokinetic parameters Cmax and AUC compared to normal reference across different populations. Groups include end-stage renal disease postdialysis, renal impairment (severe, moderate, mild), age ranges (75-83 vs. 18-43 years), body weight (<=50 kg, >120 kg vs. 70-80 kg), and hepatic impairment (moderate and mild). The X-axis represents fold change relative to reference from 0.5 to 3.1.*

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Figure 3 (Rivaroxaban 04)

A pharmacokinetic (PK) chart illustrating the fold change and 90% confidence interval (CI) of various drugs' Cmax and AUC relative to Rivaroxaban taken alone. The chart groups drugs by their interaction type, including combined P-gp and strong or moderate CYP3A inhibitors/inducers and other drugs, displaying changes in drug concentration and exposure levels versus Rivaroxaban alone.*

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Figure 9 (Rivaroxaban 10)

A forest plot comparing the primary efficacy outcome (composite of stroke, myocardial infarction, or cardiovascular death) between Rivaroxaban and placebo across various patient subgroups by age, sex, region, weight, eGFR, myocardial infarction history, stroke history, heart failure history, baseline diabetes, and peripheral artery disease (PAD). The plot includes hazard ratios with 95% confidence intervals indicating relative risk favoring either Rivaroxaban or placebo.*

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Figure 10 (Rivaroxaban 11)

A cumulative incidence rate line graph comparing Rivaroxaban and placebo over 1095 days from randomization. The solid line represents Rivaroxaban and the dashed line represents placebo, showing lower incidence for Rivaroxaban. The graph includes a hazard ratio with 95% CI for Rivaroxaban versus placebo. The number of subjects at risk is listed below the x-axis over time.*

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Figure 11 (Rivaroxaban 12)

A line graph showing cumulative incidence rate (%) on the y-axis versus days from randomization on the x-axis, comparing Rivaroxaban and Placebo treatment groups. Rivaroxaban is represented by a solid line, Placebo by a dashed line. The graph includes a hazard ratio (0.85 with 95% CI 0.76 to 0.96) and a table listing the number of subjects at risk over various time points up to 1095 days.*

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Figure 12 (Rivaroxaban 13)

A forest plot chart comparing the primary efficacy outcome of Rivaroxaban 2.5 mg tablets versus placebo, with subgroups stratified by age, sex, weight, eGFR levels, baseline diabetes, coronary artery disease, randomization strata, clopidogrel use at randomization, history of revascularization, and critical limb ischemia categories. The chart shows hazard ratios with 95% confidence intervals for each subgroup, indicating the relative effect of Rivaroxaban versus placebo on outcomes.*

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Table (Table 10)

Data table titled 'Major Bleeding Events in COMPASS - On Treatment Plus 2 Days' comparing major bleeding events in patients treated with Rivaroxaban 2.5 mg twice daily versus placebo. The table lists parameters such as modified ISTH major bleeding, fatal bleeding event types, symptomatic bleeding in critical organs, bleeding requiring reoperation, bleeding leading to hospitalization, and major gastrointestinal bleeding, with patient counts, percentages per year, and hazard ratios with 95% confidence intervals.*

* 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.