Drug Information

Product NDC: 0078-0327

Proprietary Name: Comtan

Non Proprietary Name: entacapone

Active Ingredient(s):
  • 200 mg/1 ENTACAPONE

Administration Route(s): ORAL


Pharmacy Class(es):
  • Catechol O-Methyltransferase Inhibitors [MoA];
  • Catechol-O-Methyltransferase Inhibitor [EPC]

Labeler Information

Labeler Name: Novartis Pharmaceuticals Corporation
FDA Application Number: NDA020796
Marketing Category: NDA
Start Marketing Date:10/19/1999

Package Information

No. Package Code Package Description Billing Unit
10078-0327-05100 TABLET, FILM COATED in 1 BOTTLE (0078-0327-05)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0078-0327The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEComtanThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEentacaponeThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/19/1999This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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.
APPLICATION NUMBERNDA020796This 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.
LABELER NAMENovartis Pharmaceuticals CorporationName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEENTACAPONEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESCatechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] 

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This page was last updated on: 7/22/2020