EGATEN
These highlights do not include all the information needed to use EGATEN safely and effectively. See full prescribing information for EGATEN.EGATEN (triclabendazole) tablets, for oral useInitial U.S. Approval: 2019
Approved
Approval ID
5552884e-10ea-450c-9658-d3d4f33c946e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2024
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.
triclabendazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0937
Application NumberNDA208711
Product Classification
M
Marketing Category
C73594
G
Generic Name
triclabendazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2019
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRICLABENDAZOLEActive
Quantity: 250 mg in 1 1
Code: 4784C8E03O
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYMETELLOSE (4150 MPA.S)Inactive
Code: UVP539BB9Q
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT