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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

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EGATEN - FDA Drug Approval Details