COARTEM
These highlights do not include all the information needed to use COARTEM Tablets safely and effectively. See full prescribing information for COARTEM Tablets. COARTEM (artemether and lumefantrine) tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
7866ec19-dfac-47d4-a53f-511a12643cbf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
artemether and lumefantrine
PRODUCT DETAILS
NDC Product Code0078-0568
Application NumberNDA022268
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 15, 2017
Generic Nameartemether and lumefantrine
INGREDIENTS (9)
ARTEMETHERActive
Quantity: 20 mg in 1 1
Code: C7D6T3H22J
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
LUMEFANTRINEActive
Quantity: 120 mg in 1 1
Code: F38R0JR742
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT