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  5. NDC Package Code: 52483-0014-0 Entacapone

NDC Package 52483-0014-0 Entacapone

Tablet, Film Coated - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
52483-0014-0
Package Description:
1 BAG in 1 DRUM / 62000 TABLET, FILM COATED in 1 BAG
Product Code:
52483-0014
Non-Proprietary Name:
Entacapone
Substance Name:
Entacapone
Usage Information:
This medication is used with other medications (levodopa/carbidopa) to treat Parkinson's disease. Entacapone belongs to a class of drugs known as COMT inhibitors. Many people taking levodopa for Parkinson's have problems with the effects of the levodopa wearing off between scheduled doses, causing symptoms to return or worsen. Entacapone blocks a certain natural substance (COMT enzyme) that breaks down the levodopa in the body. This effect allows the levodopa to last longer in the system so that it doesn't wear off before the next dose.
11-Digit NDC Billing Format:
52483001400
Product Type:
Drug For Further Processing
Labeler Name:
Orion Corporation, Orion Pharma
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Active Ingredient(s):
  • ENTACAPONE 200 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    03-24-2014
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 52483-0014-0?

    The NDC Packaged Code 52483-0014-0 is assigned to an UNFINISHED drug package of 1 bag in 1 drum / 62000 tablet, film coated in 1 bag of Entacapone, drug for further processing labeled by Orion Corporation, Orion Pharma. The product's dosage form is tablet, film coated and is administered via form.

    Is NDC 52483-0014 included in the NDC Directory?

    Yes, Entacapone is an UNFINISHED PRODUCT with code 52483-0014 that is active and included in the NDC Directory. The product was first marketed by Orion Corporation, Orion Pharma on March 24, 2014 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 11-digit format for NDC 52483-0014-0?

    The 11-digit format is 52483001400. 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 5-4-1 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
    5-4-152483-0014-05-4-252483-0014-00