Ivermectin
Ivermectin Tablets USP, 3mg (IVERMECTIN)
Approved
Approval ID
847a1dd7-d65b-4a0e-a67d-d90392059dac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Edenbridge Pharmaceuticals LLC.
DUNS: 948715060
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ivermectin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42799-806
Application NumberANDA204154
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ivermectin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
IVERMECTINActive
Quantity: 3 mg in 1 1
Code: 8883YP2R6D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT