Carbidopa, Levodopa And Entacapone
NDC Package 47335-005-88

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

Carbidopa, Levodopa And Entacapone is carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicated for the treatment of Parkinson’s disease.Carbidopa, levodopa and entacapone tabletscan be used: To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-005 and is authorized under FDA application NDA021485.

Identification & Billing

NDC Package Code
47335-005-88
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
47335-005
11-Digit Billing Format
47335000588
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: 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
Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa, carbidopa (dopa decarboxylase inhibitor), and entacapone (catechol-O-methyltransferase-COMT inhibitor) is indicated for the treatment of Parkinson’s disease.Carbidopa, levodopa and entacapone tabletscan be used: To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
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
04-01-2012
Listing Expiration
12-31-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 47335-005-88 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Carbidopa, Levodopa And Entacapone, labeled by Sun Pharmaceutical Industries, Inc.. 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 Sun Pharmaceutical Industries, Inc. on April 01, 2012. The current certification is valid through December 31, 2020.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335000588. 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)
47335-005-88
11-Digit CMS (5-4-2)
47335-0005-88

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