Carbidopa, Levodopa And Entacapone
NDC Package 55648-784-03

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Carbidopa, Levodopa And Entacapone is to substitute (with equivalent strength of each of the three components) for immediate-release carbidopa/levodopa and entacapone previously administered as individual products.To replace immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" (only for patients taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesias, see DOSAGE AND ADMINISTRATION). Marketed by Wockhardt Limited, this product is identified by NDC 55648-784 and is authorized under FDA application NDA021485.

Identification & Billing

NDC Package Code
55648-784-03
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
55648-784
11-Digit Billing Format
55648078403
RxNorm Crosswalk
  • RxCUI: 403850 - carbidopa 12.5 MG / levodopa 50 MG / entacapone 200 MG Oral Tablet
  • RxCUI: 403850 - carbidopa 12.5 MG / entacapone 200 MG / levodopa 50 MG Oral Tablet
  • RxCUI: 403850 - Carbidopa 12.5 MG / entacapone 200 MG / L-DOPA 50 MG Oral Tablet
  • RxCUI: 403851 - carbidopa 25 MG / levodopa 100 MG / entacapone 200 MG Oral Tablet
  • RxCUI: 403851 - carbidopa 25 MG / entacapone 200 MG / levodopa 100 MG Oral Tablet

Clinical Specifications

Proprietary Name
Carbidopa, Levodopa And Entacapone
Dosage Form
-
Usage Information
To substitute (with equivalent strength of each of the three components) for immediate-release carbidopa/levodopa and entacapone previously administered as individual products.To replace immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" (only for patients taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesias, see DOSAGE AND ADMINISTRATION).

Regulatory & Marketing

Labeler Name
Wockhardt Limited
FDA Application #
NDA021485
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
02-29-2012
Listing Expiration
12-31-2018
Exclude Flag
I
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 (55648-784). Click a package code to view its specific billing and regulatory data.

55648-784-02
100 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 55648-784-03 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Carbidopa, Levodopa And Entacapone, labeled by Wockhardt Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Wockhardt Limited on February 29, 2012. The current certification is valid through December 31, 2018.

How is this Wockhardt Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55648078403. 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)
55648-784-03
11-Digit CMS (5-4-2)
55648-0784-03

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