Ketoconazole
Ketoconazole Shampoo
Approved
Approval ID
7036d1f2-c3f9-41d4-bc72-dd70e1691128
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2020
Manufacturers
FDA
TOLMAR Inc.
DUNS: 791156578
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 Code63646-010
Application NumberANDA076942
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketoconazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 28, 2022
FDA Product Classification
INGREDIENTS (11)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IMIDUREAInactive
Code: M629807ATL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PEG-120 METHYL GLUCOSE DIOLEATEInactive
Code: YM0K64F20V
Classification: IACT
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
KETOCONAZOLEActive
Quantity: 20 mg in 1 mL
Code: R9400W927I
Classification: ACTIB
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0
Classification: IACT
DISODIUM LAURETH SULFOSUCCINATEInactive
Code: D6DH1DTN7E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT