Entacapone Tablet, Film Coated
NDC Package 52483-0014-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Entacapone tablets is a medication used with other medications (levodopa/carbidopa) to treat Parkinson's disease. This formulation utilizes a tablet, film coated delivery system. Marketed by Orion Corporation, Orion Pharma, this product is identified by NDC 52483-0014.

Identification & Billing

NDC Package Code
52483-0014-0
Package Description
1 BAG in 1 DRUM / 62000 TABLET, FILM COATED in 1 BAG
Product Code
52483-0014
11-Digit Billing Format
52483001400

Clinical Specifications

Proprietary Name
Entacapone
Non-Proprietary Name
Entacapone
Substance Name
Entacapone
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
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.

Regulatory & Marketing

Labeler Name
Orion Corporation, Orion Pharma
Product Type
Drug For Further Processing
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
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52483-0014-0 identifies a specific commercial package of 1 bag in 1 drum / 62000 tablet, film coated in 1 bag of Entacapone (UNFINISHED drug), drug for further processing labeled by Orion Corporation, Orion Pharma. This tablet, film coated is formulated for use and contains entacapone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Orion Corporation, Orion Pharma on March 24, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Orion Corporation, Orion Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52483001400. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
52483-0014-0
11-Digit CMS (5-4-2)
52483-0014-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.