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  5. NDC Package Code: 50458-575-01 Xarelto

NDC Package 50458-575-01 Xarelto

Rivaroxaban Granule, For Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50458-575-01
Package Description:
1 BOTTLE in 1 CARTON / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE
Product Code:
50458-575
Proprietary Name:
Xarelto
Non-Proprietary Name:
Rivaroxaban
Substance Name:
Rivaroxaban
Usage Information:
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.
11-Digit NDC Billing Format:
50458057501
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1114198 - rivaroxaban 10 MG Oral Tablet
  • RxCUI: 1114202 - Xarelto 10 MG Oral Tablet
  • RxCUI: 1114202 - rivaroxaban 10 MG Oral Tablet [Xarelto]
  • RxCUI: 1232082 - rivaroxaban 15 MG Oral Tablet
  • RxCUI: 1232084 - Xarelto 15 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Pharmaceuticals, Inc.
    Dosage Form:
    Granule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • RIVAROXABAN 155 mg/1
    • Pharmacologic Class(es):
  • Factor Xa Inhibitor - [EPC] (Established Pharmacologic Class)
  • Factor Xa Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA215859
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-01-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50458-575-01?

    The NDC Packaged Code 50458-575-01 is assigned to a package of 1 bottle in 1 carton / 1 granule, for suspension in 1 bottle of Xarelto, a human prescription drug labeled by Janssen Pharmaceuticals, Inc.. The product's dosage form is granule, for suspension and is administered via oral form.

    Is NDC 50458-575 included in the NDC Directory?

    Yes, Xarelto with product code 50458-575 is active and included in the NDC Directory. The product was first marketed by Janssen Pharmaceuticals, Inc. on December 01, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50458-575-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 50458-575-01?

    The 11-digit format is 50458057501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250458-575-015-4-250458-0575-01