NDC 50090-4469 Xarelto

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50090-4469
Proprietary Name:
Xarelto
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Start Marketing Date: [9]
07-01-2011
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
RED (C48326 - LIGHT RED)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
10;XA
Score:
1

Product Packages

NDC Code 50090-4469-0

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 50090-4469?

The NDC code 50090-4469 is assigned by the FDA to the product Xarelto which is product labeled by A-s Medication Solutions. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50090-4469-0 90 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Xarelto?

Rivaroxaban is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge. In addition, rivaroxaban is used to treat blood clots (such as in deep vein thrombosis-DVT or pulmonary embolus-PE) and to prevent the blood clots from forming again. Rivaroxaban is an anticoagulant that works by blocking certain clotting proteins in your blood.

Which are Xarelto UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Xarelto Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Xarelto?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Rivaroxaban


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.
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Blood Thinners


What are blood thinners?

Blood thinners are medicines that prevent blood clots from forming. They do not break up clots that you already have. But they can stop those clots from getting bigger. It's important to treat blood clots, because clots in your blood vessels and heart can cause heart attacks, strokes, and blockages.

Who needs blood thinners?

You may need a blood thinner if you have:

What are the different types of blood thinners?

There are different types of blood thinners:

  • Anticoagulants, such as heparin or warfarin (also called Coumadin), slow down your body's process of making clots.
  • Antiplatelets, such as aspirin and clopidogrel, prevent blood cells called platelets from clumping together to form a clot. Antiplatelets are mainly taken by people who have had a heart attack or stroke.

How can I take blood thinners safely?

When you take a blood thinner, follow the directions carefully. Blood thinners may interact with certain foods, medicines, vitamins, and alcohol. Make sure that your health care provider knows all of the medicines and supplements you are using.

You may need regular blood tests to check how well your blood is clotting. It is important to make sure that you're taking enough medicine to prevent clots, but not so much that it causes bleeding.

What are the side effects of blood thinners?

Bleeding is the most common side effect of blood thinners. They can also cause an upset stomach, nausea, and diarrhea.

Other possible side effects can depend on which type of blood thinner that you are taking.

Call your provider if you have any sign of serious bleeding, such as:

  • Menstrual bleeding that is much heavier than normal
  • Red or brown urine
  • Bowel movements that are red or black
  • Bleeding from the gums or nose that does not stop quickly
  • Vomit that is brown or bright red
  • Coughing up something red
  • Severe pain, such as a headache or stomachache
  • Unusual bruising
  • A cut that does not stop bleeding
  • A serious fall or bump on the head
  • Dizziness or weakness

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".