NDC Package 0378-9080-01 Entacapone

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

0378-9080-01

Package Description:

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Product Code:

0378-9080

Proprietary 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:

00378908001

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

Labeler Name:

Mylan Pharmaceuticals Inc.

Sample Package:

FDA Application Number:

NDA020796

Marketing Category:

NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Start Marketing Date:

06-26-2013

End Marketing Date:

08-31-2022

Listing Expiration Date:

08-31-2022

Exclude Flag:

Code Structure:

0378 - Mylan Pharmaceuticals Inc.
- 0378-9080 - Entacapone
  - 0378-9080-01 - 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

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 0378-9080-01?

The NDC Packaged Code 0378-9080-01 is assigned to a package of 100 tablet, film coated in 1 bottle, plastic of Entacapone, labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

Is NDC 0378-9080 included in the NDC Directory?

No, Entacapone with product code 0378-9080 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Mylan Pharmaceuticals Inc. on June 26, 2013 and its listing in the NDC Directory is set to expire on August 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0378-9080-01?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 0378-9080-01?

The 11-digit format is 00378908001. 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 4-4-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0378-9080-01	5-4-2	00378-9080-01

Table of Contents