Fluocinonide
Fluocinonide Cream USP, 0.05%
Approved
Approval ID
8ac0ecd6-38b5-a5f9-e053-2a95a90af412
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 18, 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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-4921
Application NumberANDA071500
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (8)
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
1,2,6-HEXANETRIOLInactive
Code: W45XXM0XWE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT