KETOCONAZOLE
Ketoconazole Tablets, USP200 mgRx Only
Approved
Approval ID
57e81e13-b395-4dbd-b660-3038de41a838
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Burel Pharmaceuticals, LLC
DUNS: 609436204
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ketoconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35573-433
Application NumberANDA075912
Product Classification
M
Marketing Category
C73584
G
Generic Name
ketoconazole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (5)
KETOCONAZOLEActive
Quantity: 200 mg in 1 1
Code: R9400W927I
Classification: ACTIB
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT