Rivaroxaban Tablet, Film Coated
Product Images NDC 14445-183

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Rivaroxaban (NDC 14445-183). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Indoco Remedies 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-04 (Figure 04)

A line graph comparing cumulative event rates (%) over days from randomization for Rivaroxaban and Warfarin. The x-axis represents days from 0 to 900, and the y-axis shows cumulative event rates up to 6%. Two lines plot event rates for Rivaroxaban (solid) and Warfarin (dotted), with subject numbers at risk listed below. A hazard ratio with 95% confidence interval is noted on the graph.*

FDA Label Image

Figure-05 (Figure 05)

A data table comparing event rates and hazard ratios between Rivaroxaban and Warfarin across various patient subgroups. The table includes columns for patient categories, number and percentage of events per year for each drug, and forest plot hazard ratios with 95% confidence intervals favoring Rivaroxaban or Warfarin. Subgroups include age, gender, weight, prior stroke or TIA, diabetic status, CHADS2 score, creatinine clearance, geographic region, and aspirin use at randomization.*

FDA Label Image

Figure-08 (Figure 08)

A Kaplan-Meier cumulative event rate curve comparing Rivaroxaban and Aspirin over 367 days from randomization. The graph shows cumulative event rates (%) on the y-axis and days on the x-axis. Below the x-axis, the number of subjects at risk at various time points is provided for both drugs. The graph includes a hazard ratio with 95% confidence interval for Rivaroxaban versus Aspirin.*

FDA Label Image

Figure-10 (Figure 10)

A Kaplan-Meier cumulative incidence curve showing the percentage incidence rate over days from randomization for Rivaroxaban versus placebo. The graph includes a table of the number of subjects at risk for each group at various time points and provides a hazard ratio with confidence interval comparing Rivaroxaban to placebo.*

FDA Label Image

Figure-11 (Figure 11)

A cumulative incidence rate (%) line graph comparing Rivaroxaban and placebo over days from randomization up to 1095 days. The solid line represents Rivaroxaban, and the dashed line represents placebo, showing a lower cumulative incidence rate for Rivaroxaban. The graph includes a hazard ratio with 95% confidence interval (0.85, 0.76 to 0.96) and a table showing the number of subjects at risk for both groups at multiple time points.*

FDA Label Image

Figure-12 (Figure 12)

A forest plot displaying the primary efficacy outcome percentages per year comparing Rivaroxaban to placebo across various subgroups such as age, sex, weight, eGFR, baseline diabetes, CAD, randomization strata, clopidogrel use, history of revascularization, and critical limb ischemia categories. The plot includes hazard ratios with 95% confidence intervals indicating the relative risks favoring either Rivaroxaban or placebo.*

FDA Label Image

Container-label-10mg-30s (Riva 10mg 30s)

Rivaroxaban Tablets USP 10 mg film-coated tablets, packaged in a container of 30 tablets. The label includes storage instructions, manufacturer details (Indoco Remedies Ltd.), and dosage information. It features a barcode and advises dispensing the accompanying medication guide to patients.*

FDA Label Image

Container-label-2.5mg-60s (Riva 2 5 60s)

Label for Rivaroxaban Tablets USP 2.5 mg film-coated oral tablets by Indoco Remedies Ltd. The package contains 60 tablets and includes storage instructions, a barcode, and manufacturer details from Verna, Goa, India. The label states Rx only and advises dispensing the accompanying medication guide.*

FDA Label Image

Rivaroxaban Carton 2 (Rivaroxaban Carton 2)

Packaging label for Rivaroxaban Tablets USP 20 mg film-coated tablets, manufactured by Indoco Remedies Limited. The label indicates a package containing 100 tablets in 10 blister strips of 10 tablets each, marked for hospital use only and not child resistant. Storage and dosage instructions are provided, along with barcode and manufacturer address details.*

FDA Label Image

Rivaroxaban Container 1 (Rivaroxaban Container 1)

Rivaroxaban Tablets USP 15 mg film-coated tablets label. The label includes dosage instructions, storage conditions between 20ºC to 25ºC, and a warning to keep out of reach of children. It states the product is manufactured by Indoco Remedies Limited in Goa, India, and contains 30 tablets per package. The label features a barcode, medication guide reminder, and various product identifiers including NDC 14445-183-30.*

FDA Label Image

Rivaroxaban Container 3 (Rivaroxaban Container 3)

Packaging label for Rivaroxaban Tablets USP 20 mg oral film-coated tablets, containing 30 tablets per package. The label indicates the product is manufactured by Indoco Remedies Ltd., Verna, Goa, India. The label includes storage instructions, a barcode, and reminders to dispense the accompanying Medication Guide. The label also states Rx only and includes a section for GTIN, serial number, expiration, and lot information.*

FDA Label Image

Rivaroxaban Starter Pack (Rivaroxaban Starter Pack)

Packaging label for Rivaroxaban Tablets USP, a human prescription drug presented as film-coated tablets. The label shows a starter pack containing 15 mg and 20 mg strengths, specifying 42 tablets of 15 mg to be taken twice daily for days 1-21 and 9 tablets of 20 mg to be taken once daily for days 22-30. The labeler is Indoco Remedies Limited, and storage and usage instructions are included.*

* 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.