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Rivaroxaban Granule For Suspension
Product Images NDC 70748-355
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 27 technical images submitted to the FDA as part of the official labeling for Rivaroxaban Granule (NDC 70748-355). 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
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This is a dosing aid tool that provides measurements in milliliters. It features a color band on one side to help withdraw the correct prescribed dose easily.*
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This text provides instructions for using a bottle adaptor with a cap. It advises not to remove the bottle adaptor.*
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This appears to be a guide for measuring doses of medication. The text shows different dose measures for specific amounts in milliliters. The formats include a single amount of liquid or a combination of multiple amounts. This guide can be useful for correctly measuring doses for medication or other liquid substances.*
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This text provides a cautionary note advising individuals to ensure they have an adequate amount of medicine for a complete dose, emphasizing against taking a partial dose. It serves as a reminder to follow proper medication dosing instructions for optimal effectiveness.*
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This text advises not to put the oral dosing syringe in the dishwasher. It is a precaution to ensure the proper use and maintenance of the syringe.*
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This text provides instructions for properly using a bottle of medication. It emphasizes shaking the bottle slowly for 10 seconds before each use to prevent foaming, which can result in an incorrect dosage being administered. It underlines the importance of following the shaking guidelines to ensure the accurate delivery of the medication.*
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This text provides information on Population Description, PK Fold Change, and 90% CI for different conditions such as End-Stage Renal Disease, Renal Impairment, Age, Body Weight, and Hepatic Impairment. It includes details on fold changes relative to the reference group in various categories, along with specific criteria for creatinine clearance levels. The data seems to pertain to the pharmacokinetics of rivaroxaban in individuals with different health conditions and demographics.*
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This dataset provides information on the potential impact of various drugs on drug metabolism through interactions with P-gp and CYP3A enzymes. The text includes data on the fold change in drug PK (pharmacokinetics) and corresponding 90% confidence intervals for different drugs, such as ketoconazole, ritonavir, erythromycin, clarithromycin, rifampicin, atorvastatin, clopidogrel, digoxin, enoxaparin, midazolam, naproxen, omeprazole, ranitidine, among others. The information is organized based on the type of enzyme inhibition or induction exhibited by the drugs in question. Quite detailed pharmacokinetic data is presented in this text.*
Container Label (C2a8f095 D977 4971 B77a 20feb09a6c3c 04)
This is a description of Rivaroxaban for Oral Suspension, with a concentration of 1mg/mL when reconstituted. The medication guide needs to be dispensed to each patient. It is indicated for oral use only. The bottle should be shaken slowly before each dose, and if lumps or granules are present, shaking the bottle again for 10 seconds is recommended. The bottle contains 155mg of rivaroxaban USP. The recommended dosage can be found in the prescribing information. It is advised to store the syringes and bottle upright in the original carton, and store the granules and reconstituted suspension at room temperature. Manufactured by Lupin Pharmaceuticals in the United States.*
Carton Label (C2a8f095 D977 4971 B77a 20feb09a6c3c 05)
This is a detailed description of instructions and information related to a pharmaceutical product named Rivaroxaban. It is an oral suspension with a concentration of 1mg/mL when reconstituted. The text provides guidance on how to prepare and administer the medication, storage instructions, manufacturer details (Lupin Pharmaceuticals and Lupin Limited), and safety precautions. The description also includes the dosage amount, details on necessary accessories such as dosing syringes and bottle adaptors, along with how to handle the product and information on keeping it out of reach of children. The text emphasizes reconstitution before dispensing and counselling caregivers on proper usage. It also highlights the importance of including a Medication Guide with each patient's prescription and mentions the need to use the suspension within 60 days after reconstitution.*
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* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
