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
NDC Product Code68788-8174
Application NumberANDA076005
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMay 22, 2023
Generic NameEconazole Nitrate
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