Econazole Nitrate
Econazole Nitrate Cream, 1%
Approved
Approval ID
b0c90efd-d9a2-4120-aa17-33a9d50f7347
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Econazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-8645
Application NumberANDA076479
Product Classification
M
Marketing Category
C73584
G
Generic Name
Econazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 17, 2023
FDA Product Classification
INGREDIENTS (7)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PEG-5 OLEATEInactive
Code: 0240V77G50
Classification: IACT
ECONAZOLE NITRATEActive
Quantity: 10 mg in 1 g
Code: H438WYN10E
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEGOXOL 7 STEARATEInactive
Code: 3EW5AXE5X5
Classification: IACT