Entacapone Tablet, Film Coated
NDC Package 65862-654-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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 Aurobindo Pharma Limited, this product is identified by NDC 65862-654 and is authorized under FDA application ANDA203437.

Identification & Billing

NDC Package Code
65862-654-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
65862-654
11-Digit Billing Format
65862065401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
RxCUI: 317094 - entacapone 200 MG Oral Tablet

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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ENTACAPONE 200 mg/1
Pharmacologic Class
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
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA203437
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-19-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-654). Click a package code to view its specific billing and regulatory data.

65862-654-99
1000 TABLET, FILM COATED in 1 BOTTLE

* 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 65862-654-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Entacapone, a human prescription drug labeled by Aurobindo Pharma Limited. This tablet, film coated is formulated for oral 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 Aurobindo Pharma Limited on June 19, 2015. 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 Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862065401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (5-3-2)
65862-654-01
11-Digit CMS (5-4-2)
65862-0654-01

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