Rivaroxaban Tablet, Film Coated
Product Images NDC 59651-849

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 59651-849). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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

Figure 1 (Rivaroxaban Fig1)

This text provides a breakdown of data related to patients involved in a study. It includes information such as the percentage of patients with prior warfarin/VKA usage, age groups, gender distribution, weight categories, prior stroke/TIA incidence, diabetic status, CHADS2 score, CrCl levels, geographic distribution, and randomization status for the treatment. Additionally, the text presents Hazard Ratios (HR) and 95% Confidence Intervals (95% CIs) for comparing the outcomes between Rivaroxaban and Warfarin treatments in various subgroups. This data can be used for analyzing the effectiveness of the two treatments in different patient populations.*

FDA Label Image

Figure 10 (Rivaroxaban Fig10)

This text provides information on a study involving Rivaroxaban versus Placebo, including data on the number of subjects at risk, comparison of Hazard Ratio with confidence intervals, and the days from randomization. Additionally, it mentions that all patients received aspirin 100 mg once daily as background therapy.*

FDA Label Image

Figure 11 (Rivaroxaban Fig11)

This text provides a data table comparing the number of subjects at risk over time for a treatment group receiving Rivaroxaban and a group receiving Placebo. The table includes the days from randomization and the number of subjects at risk on each day for both groups. This information can be used to evaluate the effectiveness of Rivaroxaban compared to Placebo in a clinical trial setting.*

FDA Label Image

Figure 12 (Rivaroxaban Fig12)

FDA Label Image

Package Label-principal Display Panel (2.5 mg (60 Tablets Bottle))

This is a description of a medication called Rivaroxaban Tablets, USP, with a strength of 2.5 mg per film-coated tablet. The text includes instructions for pharmacists to dispense a Medication Guide to each patient, information about storage conditions, manufacturer details, and a website for printing Medication Guides. Details such as the National Drug Code (NDC) and dosage information are available for reference. Additionally, the text mentions that the medication is distributed by Aurobindo Pharma USA, Inc., with production in India and specifications for packaging coding.*

FDA Label Image

Figure 2: Effect Of Specific Adult Populations On The Pharmacokinetics Of Rivaroxaban (Rivaroxaban Fig2)

This description provides population data and fold change with 90% confidence intervals for different conditions such as end-stage renal disease, renal impairment, age, body weight, and hepatic impairment. It also details the specific criteria for each condition, including creatinine clearance levels and the context of the study related to rivaroxaban.*

FDA Label Image

Figure 3: Effect Of Coadministered Drugs On The Pharmacokinetics Of Rivaroxaban In Adults (Rivaroxaban Fig3)

This text appears to be a list evaluating the fold change and 90% Confidence Interval (CI) of drug interactions with Rivaroxaban, a medication. It includes information on different types of inhibitors and inducers of P-glycoprotein (P-gp) and Cytochrome P450 3A (CYP3A) enzymes, as well as the effects of various other drugs on the pharmacokinetics (PK) of Rivaroxaban. The text also mentions the change relative to Rivaroxaban alone.*

FDA Label Image

Figure 4 (Rivaroxaban Fig4)

FDA Label Image

Figure 5 (Rivaroxaban Fig5)

FDA Label Image

Fig7 (Rivaroxaban Fig6)

This is a statistical data table comparing the event rates (%) between Enoxaparin/VKA and Rivaroxaban treatments over time (measured in days) with the number of patients at risk for each treatment group. The Hazard Ratio (HR) with 95% confidence interval is also provided.*

FDA Label Image

Fig8 (Rivaroxaban Fig7)

FDA Label Image

Fig8 (Rivaroxaban Fig8)

FDA Label Image

Figure 9 (Rivaroxaban Fig9)

FDA Label Image

Chemical Structure (Rivaroxaban Str)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.