NDC 55648-782 Carbidopa, Levodopa And Entacapone

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
55648-782
Proprietary Name:
Carbidopa, Levodopa And Entacapone
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Wockhardt Limited
Labeler Code:
55648
Start Marketing Date: [9]
02-29-2012
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - BROWNISH-OR GREYISH-RED)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
W782
Score:
1

Product Packages

NDC Code 55648-782-02

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC Code 55648-782-03

Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 55648-782?

The NDC code 55648-782 is assigned by the FDA to the product Carbidopa, Levodopa And Entacapone which is product labeled by Wockhardt Limited. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 55648-782-02 100 tablet, film coated in 1 bottle , 55648-782-03 500 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Carbidopa, Levodopa And Entacapone?

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).

Which are Carbidopa, Levodopa And Entacapone UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Carbidopa, Levodopa And Entacapone Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Carbidopa, Levodopa And Entacapone?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".