Quick answers
- What is Rivaroxaban used for?
- The FDA-approved label (Xarelto, Janssen Pharmaceuticals, Inc., September 10, 2026) says: “XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation for treatment of deep vein thrombosis (DVT) for treatment of pulmonary embolism (PE) for reduction in the risk of recurrence of DVT or PE for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery for prophylaxis of venous thromboembolism (VTE) in …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Rivaroxaban have a boxed warning?
- Yes. The FDA label for Xarelto has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Rivaroxaban?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated September 18, 2026). Ask your pharmacist about alternatives.
- Has Rivaroxaban been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 17, 2014 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Rivaroxaban?
- 24 companies list prescription products of Rivaroxaban in the FDA NDC Directory, including Janssen Pharmaceuticals, Inc., Indoco Remedies Limited and Alembic Pharmaceuticals Limited.
What Rivaroxaban is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation for treatment of deep vein thrombosis (DVT) for treatment of pulmonary embolism (PE) for reduction in the risk of recurrence of DVT or PE for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery for prophylaxis of venous thromboembolism (VTE) in …
— FDA label: Xarelto, Janssen Pharmaceuticals, Inc., effective September 10, 2026. Read the full label on DailyMed →
The FDA has 26 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
26 of 26 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Granule, for suspension · Tablet, coated · For suspension |
|---|---|
| Route | Oral |
| Prescription products | 44 in the FDA NDC Directory |
| Brand names | Xarelto |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| rivaroxaban 10 mg tablet, film coated | Brand: Xarelto | $19.52 per tablet |
| rivaroxaban 15 mg tablet, film coated | Brand: Xarelto | $19.53 per tablet |
| rivaroxaban 155 mg for suspension | Generic | $1.81 per mL |
| rivaroxaban 155 mg granule, for suspension | Generic | $1.81 per mL |
| rivaroxaban 155 mg granule, for suspension | Brand: Xarelto | $3.76 per mL |
| rivaroxaban 2.5 mg tablet | Generic | $0.6265 per tablet |
| rivaroxaban 2.5 mg tablet, coated | Generic | $0.6265 per tablet |
| rivaroxaban 2.5 mg tablet, film coated | Generic | $0.6265 per tablet |
| rivaroxaban 2.5 mg tablet, film coated | Brand: Xarelto | $9.78 per tablet |
| rivaroxaban 20 mg tablet, film coated | Brand: Xarelto | $19.54 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Janssen Pharmaceuticals, Inc.5 products
- Indoco Remedies Limited4 products
- Alembic Pharmaceuticals Limited4 products
- A-S Medication Solutions4 products
- Alembic Pharmaceuticals Inc.4 products
- Changzhou Pharmaceutical Factory3 products
- Cardinal Health 107, LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Apotex Corp.1 product
- Ascend Laboratories, LLC1 product
- Florida Pharmaceutical Products, LLC1 product
- Macleods Pharmaceuticals Limited1 product
- ScieGen Pharmaceuticals, Inc.1 product
- Lifestar Pharma LLC1 product
- Novadoz Pharmaceuticals LLC1 product
- Micro Labs Limited1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Aurobindo Pharma Limited1 product
- Camber Pharmaceuticals, Inc.1 product
- NorthStar RxLLC1 product
- Exelan Pharmaceuticals Inc.1 product
- XLCare Pharmaceuticals, Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022406 XARELTO | Janssen Pharms | July 1, 2011 | 34, latest March 24, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA215859 XARELTO | Janssen Pharms | December 20, 2021 | 3, latest March 24, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
Generic approvals (16)
- ANDA208555Lupin · March 3, 2025
- ANDA208557Taro · March 3, 2025
- ANDA208544Aurobindo Pharma Ltd · April 10, 2025
- ANDA217810Apotex · May 2, 2025
- ANDA208534DR Reddys · May 14, 2025
- ANDA210301Alembic · May 14, 2025
- ANDA213114Macleods Pharms · May 14, 2025
- ANDA216995Aiping Pharm Inc · May 14, 2025
- ANDA219332Ascent Pharms Inc · May 14, 2025
- ANDA218502Alkem Labs Ltd · June 26, 2025
- ANDA218117Sciegen Pharms · July 31, 2025
- ANDA218445Regcon Holdings · August 11, 2025
- ANDA218195Lupin · September 25, 2025
- ANDA208546Msn · October 24, 2025
- ANDA208334Micro Labs · June 30, 2026
- ANDA220874Mankind Pharma · July 1, 2026
Shortage status
To be discontinued · updated September 18, 2026 · first posted September 18, 2026
| Product | Xarelto, For Suspension, 155 mg (NDC 50458-575-01) |
|---|---|
| Company | Janssen Pharmaceuticals |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 17, 2014 · Class II · Terminated · D-0006-2015
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99 — Janssen Ortho L.L.C.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xarelto, Janssen Pharmaceuticals, Inc., effective September 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →