Rivaroxaban Tablet, Film Coated
Product Images NDC 60505-6256

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 60505-6256). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

Btl-lbl-500s.jpg (Btl Lbl 500s)

The image shows a drug label for Rivaroxaban Tablets, USP, 2.5 mg, film-coated oral tablets. The label indicates a package size of 500 tablets and includes storage instructions (20°C to 25°C, with permitted excursions). The manufacturer is Apotex Inc., Toronto, Ontario, and the labeler is Apotex Corp., Weston, Florida. The label includes the product NDC 60505-6256-5 and a barcode.*

FDA Label Image

Btl-lbl-60s.jpg (Btl Lbl 60s)

Rivaroxaban Tablets, USP 2.5 mg film-coated tablets label by Apotex Corp. The package contains 60 tablets with storage instructions and a barcode. Manufactured by Apotex Inc., Toronto, Ontario, Canada, and for Apotex Corp., Weston, Florida.*

FDA Label Image

Figure10.jpg (Figure10)

A line graph showing the cumulative incidence rate (%) over days from randomization (0 to 1095) comparing Rivaroxaban and Placebo. The graph includes two curves: a solid line for Rivaroxaban and a dashed line for Placebo, with the Placebo group having a higher cumulative incidence rate throughout. Below the graph, the number of subjects at risk is listed for both groups at multiple time points. A hazard ratio for Rivaroxaban versus Placebo with 95% confidence interval is also shown.*

FDA Label Image

Figure11.jpg (Figure11)

A line chart depicting the cumulative incidence rate (%) over days from randomization for two treatment groups: Rivaroxaban and Placebo. The graph shows time on the x-axis (0 to 1095 days) and cumulative incidence rate on the y-axis (0 to 25%). It includes a legend and a table displaying the number of subjects at risk for each group at various time points. The chart also notes a hazard ratio with a 95% confidence interval comparing Rivaroxaban versus Placebo.*

FDA Label Image

Figure12.jpg (Figure12)

A forest plot chart visually comparing the primary efficacy outcome of Rivaroxaban versus placebo across various subgroups including age, sex, weight, eGFR, baseline diabetes, coronary artery disease (CAD), randomization strata, clopidogrel use, history of revascularization, and critical limb ischemia categories. The chart shows hazard ratios with 95% confidence intervals, illustrating relative risk favoring Rivaroxaban or placebo for each subgroup.*

FDA Label Image

Figure2.jpg (Figure2)

A fold change and 90% confidence interval chart displaying pharmacokinetic (PK) data for rivaroxaban. It compares Cmax and AUC values for various population groups, including end-stage renal disease (postdialysis), renal impairment (severe, moderate, mild), age groups (75-83 years vs 18-43 years), body weight categories (<=50 kg/70-80 kg and >120 kg/70-80 kg), and hepatic impairment (moderate and mild). The x-axis shows change relative to reference values.*

FDA Label Image

Figure3.jpg (Figure3)

A forest plot chart illustrating the pharmacokinetic effects on Rivaroxaban when combined with various interacting drugs. The chart categorizes drugs by type of inhibitor or inducer (e.g., strong or moderate CYP3A inhibitors), showing fold changes and 90% confidence intervals for maximum concentration (Cmax) and area under the curve (AUC) relative to Rivaroxaban alone. Drugs listed include ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, rifampicin, and others like aspirin and warfarin.*

FDA Label Image

Figure9.jpg (Figure9)

A forest plot comparing the primary efficacy outcome (composite of stroke, MI, or CV death) between Rivaroxaban 2.5 mg and placebo across various subgroups. The plot shows hazard ratios with 95% confidence intervals for age, sex, region, weight, eGFR, MI history, stroke history, prior heart failure, baseline diabetes, and PAD. The x-axis ranges from 0.25 to 3, indicating the direction of treatment effect favoring either Rivaroxaban or placebo.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure of rivaroxaban, a small molecule with multiple ring systems including a chlorinated thiophene and oxazolidinone moieties, depicted with standard bond-line notation.*

* 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.