STROMECTOL
STROMECTOL® (IVERMECTIN) TABLETS
Approved
Approval ID
5d140f06-e46b-4cdd-97e4-37b6cf4ade13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2016
Manufacturers
FDA
Department of State Health Services, Pharmacy Branch
DUNS: 781992540
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 Code55695-019
Application NumberNDA050742
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivermectin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2016
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
IVERMECTINActive
Quantity: 3 mg in 1 1
Code: 8883YP2R6D
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT