Econazole Nitrate
Econazole Nitrate Cream 1%
Approved
Approval ID
6989d30f-9bb7-4e6e-92de-05e9f9a4f523
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-8174
Application NumberANDA076005
Product Classification
M
Marketing Category
C73584
G
Generic Name
Econazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 22, 2023
FDA Product Classification
INGREDIENTS (9)
benzoic acidInactive
Code: 8SKN0B0MIM
Classification: IACT
PEG-6 stearateInactive
Code: 8LQC57C6B0
Classification: IACT
apricot kernel oil PEG-6 estersInactive
Code: DRG3KJZ1TJ
Classification: IACT
Econazole NitrateActive
Quantity: 10 mg in 1 g
Code: H438WYN10E
Classification: ACTIB
butylated hydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
glycol stearateInactive
Code: 0324G66D0E
Classification: IACT
PEG-32 stearateInactive
Code: 33GX5WQC0M
Classification: IACT