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  4. NDC Product Code: 55648-786 Carbidopa, Levodopa And Entacapone

NDC 55648-786 Carbidopa, Levodopa And Entacapone

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55648-786?
  5. Carbidopa, Levodopa And Entacapone Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

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

Get all the details for National Drug Code (NDC) 55648-786 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
55648-786
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
Product Label ID:
dabb7f5d-03b3-4d46-951a-e41a1f8d69cc
FDA Application Number: [6]
NDA021485
Marketing Category: [8]
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: [9]
02-29-2012
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - BROWNISH-OR GREYISH-RED)
BROWN (C48332 - LIGHT BROWNISH RED)
BROWN (C48332 - BRONISH OR GREYISH-RED)
BROWN (C48332 - BROWNISH OR GREYISH-RED)
Shape:
ROUND (C48348)
OVAL (C48345)
Size(s):
11 MM
14 MM
16 MM
15 MM
Imprint(s):
W782
W783
W784
W785
W786
Score:
1

Code Structure Chart

Product Details

What is NDC 55648-786?

The NDC code 55648-786 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 55648-786-02 100 tablet, film coated in 1 bottle , 55648-786-03 500 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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".