0078-0568 NDC - COARTEM (ARTEMETHER AND LUMEFANTRINE)

Drug Information

Product NDC: 0078-0568

Proprietary Name: COARTEM

Non Proprietary Name: artemether and lumefantrine

Active Ingredient(s):
  • 20 mg/1 ARTEMETHER;
  • 120 mg/1 LUMEFANTRINE


Administration Route(s): ORAL

Dosage Form(s): TABLET

Pharmacy Class(es):
  • Antimalarial [EPC];
  • Antimalarial [EPC]

Labeler Information

Labeler Name: Novartis Pharmaceuticals Corporation
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022268
Marketing Category: NDA
Start Marketing Date:4/7/2009

Package Information

No. Package Code Package Description Billing Unit
10078-0568-4524 TABLET in 1 BOTTLE (0078-0568-45)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0078-0568The 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 NAMECOARTEMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEartemether and lumefantrineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe 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 DATE4/7/2009This 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 NUMBERNDA022268This 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 NAMEARTEMETHER; LUMEFANTRINEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH20; 120 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAntimalarial [EPC], Antimalarial [EPC] 

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This page was last updated on: 2/1/2023