Rivaroxaban Tablet, Film Coated
Product Images NDC 33342-488

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 33342-488). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods Pharmaceuticals 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.

FDA Label Image

Rivaroxaban-carton-2-5mg (Rivaroxaban Carton 2 5mg)

Packaging label for Rivaroxaban Tablets, USP 2.5 mg film-coated tablets by Macleods Pharmaceuticals Limited. The unit dose package contains 60 tablets (10 x 6 unit dose blister cards). The label indicates oral administration and provides manufacturer details including Macleods Pharma USA, Inc., Princeton, NJ and Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. Storage instructions and a barcode are also visible.*

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Rivaroxaban-fig-01 (Rivaroxaban Fig 01)

A forest plot chart comparing hazard ratios and 95% confidence intervals between Rivaroxaban and Warfarin across various patient subgroups. The chart lists patient characteristics on the left, event rates for Rivaroxaban and Warfarin in the middle, and plots hazard ratios favoring either drug with confidence intervals visually represented by horizontal lines and squares. Numerical hazard ratio values with confidence intervals are shown on the right.*

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Fig-02 (Rivaroxaban Fig 02)

A forest plot illustrating the pharmacokinetic (PK) fold change and 90% confidence intervals (CI) for Rivaroxaban in various populations including end-stage renal disease, renal impairment, age groups, body weight categories, and hepatic impairment. The x-axis quantifies change relative to reference for Cmax and AUC parameters.*

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Fig-03 (Rivaroxaban Fig 03)

A chart illustrating the fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax and AUC) of rivaroxaban when coadministered with various interacting drugs. The graph categorizes drugs as combined P-gp and CYP3A inhibitors (strong and moderate), CYP3A inducers, and other drugs, showing how each influences rivaroxaban exposure relative to administration alone.*

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Fig-04 (Rivaroxaban Fig 04)

A line graph showing time to first occurrence of stroke or non-CNS systemic embolism comparing Rivaroxaban and Warfarin treatment groups. The x-axis represents days from randomization up to 900 days, and the y-axis shows cumulative event rates percentage. The graph includes cumulative event rates for both drugs with hazard ratio (HR) data and number of subjects at risk at various time points displayed below.*

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Fig-05 (Rivaroxaban Fig 05)

A data table comparing patient characteristics, event rates per 100 person-years, and hazard ratios with 95% confidence intervals for Rivaroxaban versus Warfarin. The table includes categories by gender, weight, stroke risk score, CHADS2 score, and geographic region, presenting statistical outcomes for each subgroup.*

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Fig-06 (Rivaroxaban Fig 06)

A cumulative event rate line graph comparing Rivaroxaban and Enoxaparin/VKA over 360 days from randomization. The y-axis represents the cumulative event rate percentage, and the x-axis shows days. Lines for both treatments depict event rates with accompanying patient risk numbers at different intervals and a hazard ratio with confidence interval presented.*

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Fig-07 (Rivaroxaban Fig 07)

A cumulative event rate graph comparing Rivaroxaban and Enoxaparin/VKA over 360 days from randomization. The y-axis represents cumulative event rate (%) and the x-axis shows days. The graph includes hazard ratio data with 95% confidence intervals, depicting patient event trends over time for both treatments.*

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Fig-08 (Rivaroxaban Fig 08)

A cumulative event rate graph comparing Rivaroxaban and Aspirin over days from randomization. The y-axis shows cumulative event rate percentage, and the x-axis shows days from randomization. The graph includes steps for both Rivaroxaban (solid line) and Aspirin (dashed line), with a table of numbers of subjects at risk below the x-axis for each treatment group at intervals.*

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Figure-10 (Rivaroxaban Figure 10)

A line graph showing the cumulative incidence rate (%) over days from randomization for Rivaroxaban compared to placebo. The solid line represents Rivaroxaban, and the dashed line represents placebo. The graph includes a hazard ratio comparing Rivaroxaban to placebo with values and a table of number of subjects at risk over time for both groups.*

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Fig-11 (Rivaroxaban Figure 11)

A cumulative incidence rate (%) line graph comparing Rivaroxaban and placebo treatment groups over 1095 days from randomization. The graph includes a hazard ratio comparison of 0.85 (95% CI: 0.76, 0.96) favoring Rivaroxaban. The x-axis is labeled 'Days from randomization,' and the y-axis is 'Cumulative Incidence Rate (%).' A table below shows the number of subjects at risk over time for each group.*

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Fig-12 (Rivaroxaban Figure 12)

A forest plot chart comparing the efficacy outcomes between Rivaroxaban and Placebo across various patient subgroups and categories. The chart includes hazard ratios (HR) with 95% confidence intervals, showing effect sizes for age, sex, weight, kidney function (eGFR), diabetes status, coronary artery disease (CAD), randomization strata, clopidogrel use, history of revascularization, and critical limb ischemia categories.*

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Fig-9 (Rivaroxaban Figure 9)

A forest plot showing the primary efficacy outcome (composite of stroke, myocardial infarction, or cardiovascular death) comparing Rivaroxaban and placebo across various demographic and clinical subgroups, with hazard ratios and confidence intervals illustrated. Subgroups include age, sex, region, weight, estimated glomerular filtration rate (eGFR), medical history, and more, indicating the relative risk favoring either Rivaroxaban or placebo.*

FDA Label Image

Rivaroxaban-label-2-5mg-60s-count (Rivaroxaban Label 2 5mg 60s Count)

Rivaroxaban Tablets USP 2.5 mg film-coated oral tablets packaging label. The label shows the product name, strength, quantity of 60 tablets, manufacturer Macleods Pharmaceuticals Limited, and distributor Macleods Pharma USA, Inc. It includes storage instructions, a barcode, and dispensing guidance.*

FDA Label Image

Str (Rivaroxaban Str)

Chemical structure of Rivaroxaban, the active ingredient in the product. The diagram shows the molecular configuration including rings, bonds, and functional groups characteristic of this anticoagulant drug.*

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505 (Rivaroxaban Tablets 2 5 mg 180s Count)

Rivaroxaban Tablets, USP 2.5 mg film-coated tablets label from Macleods Pharmaceuticals Limited. The label indicates each tablet contains 2.5 mg rivaroxaban, with packaging for 180 tablets. It includes storage instructions, manufacturer details in India, and directs pharmacists to dispense the Medication Guide.*

* 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.