Fluocinonide
Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only
Approved
Approval ID
51f2ab70-075d-05e5-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 11, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinonide
PRODUCT DETAILS
NDC Product Code68071-1754
Application NumberANDA073085
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateFebruary 11, 2021
Generic NameFluocinonide
INGREDIENTS (6)
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
1,2,6-HEXANETRIOLInactive
Code: W45XXM0XWE
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB