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Rivaroxaban

Generic Name
Rivaroxaban
Brand Names
Xarelto, Rivaroxaban Accord, Rivaroxaban Viatris (previously Rivaroxaban Mylan)
Drug Type
Small Molecule
Chemical Formula
C19H18ClN3O5S
CAS Number
366789-02-8
Unique Ingredient Identifier
9NDF7JZ4M3

Overview

Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.

Background

Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.

Indication

Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); to reduce risk of recurrent DVT and/or PE. Rivaroxaban is also indicated, in combination with aspirin, for reducing the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. Its use is also not recommended in those with severe renal impairment (<30mL/min). Rivaroxaban is also indicated for the treatment and prevention of VTE in pediatric patients (from birth to 18 years of age) and for thromboprophylaxis in pediatric patients ≥2 years old with congenital heart disease following the Fontan procedure.

Associated Conditions

  • Cardiovascular Mortality
  • Deep Vein Thrombosis
  • Deep vein thrombosis recurrent
  • Major Adverse Cardiovascular Events
  • Myocardial Infarction
  • Pulmonary Embolism
  • Recurrent Pulmonary Embolism (Disorder)
  • Recurrent Venous Thromboembolism
  • Stroke
  • Systemic Embolism
  • Thrombosis
  • Venous Thromboembolism

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Janssen Pharmaceuticals, Inc.
50458-579
ORAL
20 mg in 1 1
11/21/2023
A-S Medication Solutions
50090-3639
ORAL
20 mg in 1 1
10/15/2018
Alembic Pharmaceuticals Limited
46708-683
ORAL
2.5 mg in 1 1
1/30/2025
Cardinal Health 107, LLC
55154-1423
ORAL
20 mg in 1 1
11/9/2021
Alembic Pharmaceuticals Limited
46708-346
ORAL
10 mg in 1 1
1/30/2025
A-S Medication Solutions
50090-3625
ORAL
10 mg in 1 1
11/21/2023
A-S Medication Solutions
50090-4469
ORAL
10 mg in 1 1
11/19/2019
Janssen Pharmaceuticals, Inc.
50458-575
ORAL
155 mg in 1 1
11/21/2023
Janssen Pharmaceuticals, Inc.
50458-580
ORAL
10 mg in 1 1
11/21/2023
Janssen Pharmaceuticals, Inc.
50458-577
ORAL
2.5 mg in 1 1
11/21/2023

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Rivaroxaban for Suspension
国药准字HJ20220044
化学药品
干混悬剂
4/29/2022
Rivaroxaban for Suspension
国药准字HJ20220045
化学药品
干混悬剂
4/29/2022
Rivaroxaban Granules
国药准字H20258003
化学药品
颗粒剂
1/8/2025
Rivaroxaban Granules
国药准字H20243387
化学药品
颗粒剂
7/30/2024
Rivaroxaban Granules
国药准字H20243982
化学药品
颗粒剂
6/11/2024
Rivaroxaban Granules
国药准字H20243981
化学药品
颗粒剂
6/11/2024
Rivaroxaban Granules
国药准字H20254065
化学药品
颗粒剂
5/13/2025
Rivaroxaban Tablets
国药准字H20247255
化学药品
片剂
10/29/2024
Rivaroxaban Tablets
国药准字H20227005
化学药品
片剂
1/18/2022
Rivaroxaban Tablets
国药准字H20258041
化学药品
片剂
3/25/2025

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
RALTEG 20 TABLETS 20MG
N/A
i & c (hong kong) limited
N/A
N/A
2/14/2025
XARELTO TABLETS 10MG
N/A
N/A
N/A
9/4/2024
XARELTO TABLETS 20MG
N/A
N/A
N/A
9/4/2024
RIVACRYST TABLETS 20MG
N/A
N/A
N/A
9/30/2024
RALTEG 10 TABLETS 10MG
N/A
i & c (hong kong) limited
N/A
N/A
2/14/2025
RIVACRYST TABLETS 10MG
N/A
N/A
N/A
9/30/2024
RALTEG 15 TABLETS 15MG
N/A
i & c (hong kong) limited
N/A
N/A
2/14/2025
XARELTO TABLETS 15MG
N/A
N/A
N/A
9/4/2024
RIVACRYST TABLETS 15MG
N/A
N/A
N/A
9/30/2024
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