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Brand-name prescription medicine

Xarelto

Generic name: Rivaroxaban

FDA application holder: Janssen Pharms

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Xarelto?
Xarelto is a brand name of Rivaroxaban, a prescription medicine. The FDA NDC Directory lists 12 Xarelto products in 5 strengths and forms.
Who makes Xarelto?
Janssen Pharms holds the FDA application for Xarelto (NDA022406, approved July 1, 2011). 3 other companies (repackagers or distributors) also list Xarelto products.
Is there a generic or store brand of Xarelto?
Yes. The FDA NDC Directory lists 26 other products with the same active ingredients, strength and form as a Xarelto product, 26 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Xarelto?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 5 Xarelto strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Xarelto been recalled?
FDA enforcement reports list 1 recall of Xarelto products; the newest started September 17, 2014. A recall usually concerns specific lots, not every product.

What Xarelto is

Each Xarelto product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Rivaroxaban · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
rivaroxaban 10 mg
tablet, film coated (oral)
Xarelto 4 products, 4 companies DailyMed
rivaroxaban 15 mg
tablet, film coated (oral)
Xarelto 4 products, 4 companies DailyMed
rivaroxaban 155 mg
granule, for suspension (oral)
Xarelto 1 product, 1 company DailyMed
rivaroxaban 2.5 mg
tablet, film coated (oral)
Xarelto 13 products, 13 companies DailyMed
rivaroxaban 20 mg
tablet, film coated (oral)
Xarelto 4 products, 4 companies DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Rivaroxaban →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Xarelto products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA022406Janssen PharmsJuly 1, 201111
NDA215859Janssen PharmsDecember 20, 20211

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.

NADAC per unit for Xarelto, by strength and form
Strength and formGeneric or brandPharmacies 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
granule, for suspension
Brand: Xarelto $3.76 per mL
Generic of the same strength and form: $1.81 per mL
rivaroxaban 2.5 mg
tablet, film coated
Brand: Xarelto $9.78 per tablet
Generic of the same strength and form: $0.6265 per tablet
rivaroxaban 20 mg
tablet, film coated
Brand: Xarelto $19.54 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 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 Xarelto

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Xarelto products.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. 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.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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