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NDC 50458-0580-30 Xarelto 10 mg/1 Details
Xarelto 10 mg/1
Xarelto is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is RIVAROXABAN.
MedlinePlus Drug Summary
Rivaroxaban is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in adults. Rivaroxaban is also used to prevent DVT and PE from happening again after initial treatment is completed in adults. It is also used to help prevent strokes or serious blood clots in adults who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) that is not caused by heart valve disease. Rivaroxaban is also used to prevent DVT and PE in adults who are having hip replacement or knee replacement surgery or in people who are hospitalized for serious illnesses and are at risk of developing a clot due to decreased ability to move around or other risk factors. It is also used along with aspirin to lower the risk of a heart attack, stroke, or death in adults with coronary artery disease (narrowing of the blood vessels that supply blood to the heart) or peripheral arterial disease (poor circulation in the blood vessels that supply blood to the arms and legs). Rivaroxaban is also used to treat and prevent DVT and PE from happening again in children and certain infants who have received at least 5 days of initial anticoagulation (blood thinner) treatment. It is also used to prevent DVT and PE after heart surgery in children 2 years of age or older who have congenital heart disease (abnormality in the heart that develops before birth). Rivaroxaban is in a class of medications called factor Xa inhibitors. It works by blocking the action of a certain natural substance that helps blood clots to form.
Related Packages: 50458-0580-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Rivaroxaban
Product Information
NDC | 50458-0580 |
---|---|
Product ID | 50458-580_0aaf0811-077b-1625-e063-6394a90a9177 |
Associated GPIs | 83370060000320 |
GCN Sequence Number | 064493 |
GCN Sequence Number Description | rivaroxaban TABLET 10 MG ORAL |
HIC3 | M9V |
HIC3 Description | DIRECT FACTOR XA INHIBITORS |
GCN | 14427 |
HICL Sequence Number | 035915 |
HICL Sequence Number Description | RIVAROXABAN |
Brand/Generic | Brand |
Proprietary Name | Xarelto |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | rivaroxaban |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/1 |
Substance Name | RIVAROXABAN |
Labeler Name | Janssen Pharmaceuticals, Inc. |
Pharmaceutical Class | Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA022406 |
Listing Certified Through | 2024-12-31 |
Package
NDC 50458-0580-30 (50458058030)
NDC Package Code | 50458-580-30 |
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Billing NDC | 50458058030 |
Package | 30 TABLET, FILM COATED in 1 BOTTLE (50458-580-30) |
Marketing Start Date | 2011-07-01 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 18.2095 |
Pricing Unit | EA |
Effective Date | 2024-01-24 |
NDC Description | XARELTO 10 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 2 |
Classification for Rate Setting | B |
As of Date | 2024-02-21 |