MedPath

STROMECTOL

STROMECTOL (IVERMECTIN)TABLETS

Approved
Approval ID

681888c9-af79-4b7d-ae80-c3f4f6f1effd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 10, 2023

Manufacturers
FDA

Merck Sharp & Dohme LLC

DUNS: 118446553

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 Code0006-0032
Application NumberNDA050742
Product Classification
M
Marketing Category
C73594
G
Generic Name
ivermectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2022
FDA Product Classification

INGREDIENTS (6)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
IVERMECTINActive
Quantity: 3 mg in 1 1
Code: 8883YP2R6D
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

STROMECTOL - FDA Drug Approval Details