Rivaroxaban Tablet, Film Coated
Product Images NDC 46708-348

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 46708-348). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic 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

30 Tablets (Rivaroxaban 10)

Rivaroxaban Tablets, USP 10 mg film-coated oral tablets in a package of 30, labeled with NDC 46708-346-30. The label includes directions to store at 25°C with permissible excursions, manufacturer information (Alembic Pharmaceuticals Limited), a barcode, and usage instructions to dispense the accompanying Medication Guide.*

FDA Label Image

51 Tablets (Rivaroxaban 15 20)

Rivaroxaban Tablets, USP Starter Pack packaging label by Alembic Pharmaceuticals Limited. The label shows film-coated tablets in 15 mg and 20 mg strengths for oral use. The starter pack is for a 30-day supply with 42 tablets of 15 mg and 9 tablets of 20 mg. Instructions on transitioning from 15 mg to 20 mg tablets on day 22 are included. The NDC number 46708-240-51 and barcode are displayed.*

FDA Label Image

30 Tablets (Rivaroxaban 15)

Rivaroxaban Tablets, USP 15 mg film-coated oral tablets, supplied in a package containing 30 tablets. The label shows the active ingredient rivaroxaban, dosage strength 15 mg, manufacturer Alembic Pharmaceuticals Limited, and storage instructions. The NDC code 46708-347-30 is visible along with a barcode.*

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60 Tablets (Rivaroxaban 2 5)

Rivaroxaban Tablets, USP 2.5 mg film-coated tablets in a 60-count package. The label includes storage instructions at 25°C (77°F) with permitted excursions and states the product is manufactured by Alembic Pharmaceuticals Limited in Gujarat, India. It also advises dispensing the Medication Guide with the prescription.*

FDA Label Image

30 Tablets (Rivaroxaban 20)

Rivaroxaban Tablets, USP 20 mg film-coated oral tablets packaging label from Alembic Pharmaceuticals Limited. The label states the active ingredient strength as 20 mg per tablet and indicates a package size of 30 tablets. It includes storage instructions and manufacturer details, along with a barcode and NDC number 46708-348-30.*

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Rivaroxaban-fig-1 (Rivaroxaban Fig 1)

A forest plot comparing hazard ratios and 95% confidence intervals for Rivaroxaban versus Warfarin across various patient subgroups. It displays data for factors such as age, gender, weight, prior stroke, diabetes status, renal function, and geographic region, illustrating comparative effectiveness between the two treatments.*

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Rivaroxaban-fig-2.jpg (Rivaroxaban Fig 2)

A chart displaying pharmacokinetic (PK) fold change and 90% confidence intervals (CI) for rivaroxaban in various populations. Variables include end-stage renal disease, renal impairment, age, body weight, and hepatic impairment, with PK parameters Cmax and AUC compared to normal reference groups. Footnotes clarify patient conditions and creatinine clearance ranges.*

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Rivaroxaban-fig-3.jpg (Rivaroxaban Fig 3)

A forest plot chart illustrating drug interaction effects on rivaroxaban pharmacokinetics, showing fold changes with 90% confidence intervals for Cmax and AUC values. It categorizes interacting drugs as combined P-gp and strong CYP3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, and other drugs, with fold changes relative to rivaroxaban alone on a logarithmic scale from 0.25 to 4.*

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Rivaroxaban-fig5.jpg (Rivaroxaban Fig5)

A forest plot compares hazard ratios and 95% confidence intervals for Rivaroxaban versus Warfarin across various patient subgroups including prior Warfarin use, age, gender, weight, prior stroke/TIA, diabetic status, CHADS2 score, creatinine clearance, geographic region, and ASA use at randomization. The plot visualizes risk estimates favoring either Rivaroxaban or Warfarin.*

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Rivaroxaban-figure10.jpg (Rivaroxaban Figure10)

A line graph comparing cumulative incidence rates (%) over days from randomization for Rivaroxaban tablets versus placebo. The solid line represents Rivaroxaban tablets and the dashed line represents placebo. The graph includes a hazard ratio comparison with 95% confidence interval: 0.74 (0.65 to 0.86). The number of subjects at risk at various time points is shown below the x-axis.*

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Rivaroxaban-figure11.jpg (Rivaroxaban Figure11)

A line graph comparing the cumulative incidence rate (%) over time (days from randomization) between Rivaroxaban Tablets and Placebo treatment groups. The x-axis shows days up to 1095, and the y-axis shows cumulative incidence rate up to 25%. The solid line represents Rivaroxaban Tablets, while the dashed line represents Placebo. The graph includes a hazard ratio comparison (0.85 with 95% CI 0.76 to 0.96). A table below the graph lists the number of subjects at risk for each group at various time points.*

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Rivaroxaban-figure12.jpg (Rivaroxaban Figure12)

A forest plot chart comparing hazard ratios (HR) with 95% confidence intervals for Rivaroxaban tablets versus placebo across various patient subgroups and outcomes. The chart presents efficacy data for age, sex, weight, eGFR, baseline diabetes, coronary artery disease (CAD), randomization strata, clopidogrel use, history of revascularization, and critical limb ischemia categories.*

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Rivaroxaban-figure4.jpg (Rivaroxaban Figure4)

A line graph comparing the cumulative event rate (%) over days from randomization for Rivaroxaban Tablets and Warfarin. The X-axis represents days from 0 to 900, and the Y-axis shows event rate from 0% to 6%. The solid line represents Rivaroxaban Tablets, and the dashed line represents Warfarin, with Rivaroxaban showing a consistently lower cumulative event rate. A hazard ratio (HR) with 95% confidence interval (CI) is noted in the lower right corner.*

FDA Label Image

Rivaroxaban-figure6.jpg (Rivaroxaban Figure6)

A line graph comparing cumulative event rates over time in days from randomization between two treatment groups: Enoxaparin/VKA and Rivaroxaban Tablets. The x-axis represents days up to 360, and the y-axis shows cumulative event rate percentage up to 4%. The graph includes a hazard ratio (HR) with 95% confidence interval (CI) for the comparison.*

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Rivaroxaban-figure7.jpg (Rivaroxaban Figure7)

A Kaplan-Meier curve showing the cumulative event rate (%) over days from randomization for Enoxaparin/VKA and Rivaroxaban Tablets. The x-axis represents time in days up to 360 days, and the y-axis indicates the cumulative event rate percentage up to 4%. Enoxaparin/VKA is shown with a dashed line, and Rivaroxaban Tablets are shown with a solid line. The graph includes a hazard ratio (HR) with 95% confidence interval (CI) reported as 1.12 (0.75, 1.68).*

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Rivaroxaban-figure8.jpg (Rivaroxaban Figure8)

A cumulative event rate line graph comparing Rivaroxaban tablets (solid line) and aspirin (dashed line) over 367 days from randomization. The y-axis shows cumulative event rate (%) and the x-axis shows days. The graph includes a table of number of subjects at risk for each treatment over time and a hazard ratio (95% CI) of 0.26 (0.14 to 0.47).*

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Rivaroxaban-figure9.jpg (Rivaroxaban Figure9)

A forest plot chart comparing the primary efficacy outcomes of Rivaroxaban tablets versus placebo across various patient subgroups. It shows hazard ratios with 95% confidence intervals depicting efficacy in categories such as age, sex, region, weight, kidney function, myocardial infarction history, stroke history, heart failure history, baseline diabetes, and bleeding adverse events. The chart visually indicates the favorability of Rivaroxaban tablets over placebo for stroke, MI, or cardiovascular death outcomes.*

FDA Label Image

Rivaroxaban-str (Rivaroxaban Structure)

Chemical structure of Rivaroxaban, showing its molecular framework with a chlorothiophene, lactam, and oxazolidinone functional groups as depicted in the image.*

* 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.