Rivaroxaban Tablet, Film Coated
Product Images NDC 68180-709
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Product Visual Gallery
This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 68180-709). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Lupin Pharmaceuticals, 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.
Product Images & Figures Index
Figure 3 (186d9028 88fd 4703 804c 2e3c98a5b007 02)
This text provides information on Population Description PK Fold Change and 90% CI for various conditions such as End-Stage Renal Disease, Renal Impairment, Age, Body Weight, and Hepatic Impairment. The data includes comparisons between different groups (e.g., Normal vs. Severe, Moderate) and criteria like Creatinine clearance for specific ranges. It also mentions the use of rivaroxaban in ESRD subjects undergoing hemodialysis.*
Image (186d9028 88fd 4703 804c 2e3c98a5b007 03)
This text provides information on the drug interactions and the fold change in pharmacokinetics (PK) along with the 90% confidence interval. It includes details on combined P-glycoprotein (P-gp) and strong CYP3A4 inhibitors (such as Ketoconazole, Ritonavir, and Clarithromycin), moderate CYP3A4 inhibitors (including Erythromycin and Fluconazole), strong CYP3A4 inducers (like Rifampicin), and other drugs (like Aspirin, Atorvastatin, Digoxin, and Warfarin). The data presented seems to focus on the impact of these interactions on parameters such as Cmax (maximum concentration) and AUC (area under the curve) for various medications.*
Fig 9 (186d9028 88fd 4703 804c 2e3c98a5b007 04)
This text appears to contain data related to the evaluation of a medical study comparing the medication Rivaroxaban to a placebo in different age groups, genders, regions, weights, kidney functions, and medical histories. It also includes the efficacy outcomes in terms of a composite measure of stroke, heart attack, or vascular death. The results are presented in percentages and hazard ratios. The study seems to have assessed various factors such as sex, age, weight, kidney function, stroke history, heart failure history, prior diabetes, and peripheral artery disease. Overall, the findings suggest a comparison between Rivaroxaban and the placebo in different subgroups based on the specified parameters.*
Figure 10 (186d9028 88fd 4703 804c 2e3c98a5b007 05)
Figure 11 (186d9028 88fd 4703 804c 2e3c98a5b007 06)
Figure 12 (186d9028 88fd 4703 804c 2e3c98a5b007 07)
This text appears to be a table containing different percentages and outcomes related to a study, such as primary efficacy outcomes, gender distribution (male vs. female), weight categories, baseline diabetes status, randomization strata, use of clopidogrel, history of revascularization, and various numerical data related to Rivarozaban and Placebo. The table also includes statistics such as HR (Hazard Ratios) with their corresponding 95% confidence intervals. The information is likely from a clinical trial or medical study evaluating the effectiveness of different treatments in patients with specific conditions.*
Container 2.5 mg (186d9028 88fd 4703 804c 2e3c98a5b007 08)
This is a description for Rivaroxaban tablets, containing 2.5mg of Rivaroxaban USP in each tablet. The usual dosage information should be referred to in the accompanying prescribing information. The tablets should be stored at room temperature with excursions permitted within a certain range. The medication guide should be dispensed to each patient and kept out of reach of children. The tablets are manufactured by Lupin Pharmaceuticals in India.*
Container 2.5 mg (186d9028 88fd 4703 804c 2e3c98a5b007 09)
This is a description for Rivaroxaban tablets, sized 50x18mm, with 30 tablets in the pack. They are USP approved and should be stored at or below 25°C (77°F). The product is manufactured by Lupin Pharmaceuticals, Inc. in India. The medication guide should be dispensed to each patient, and the tablets should be kept out of reach of children.*
Image (186d9028 88fd 4703 804c 2e3c98a5b007 689 1)
Image (186d9028 88fd 4703 804c 2e3c98a5b007 711 1)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.