Fluocinonide
Approved
Approval ID
c095ffa5-3786-44ef-9a66-e8441e39dee1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-3435
Application NumberANDA073481
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2010
FDA Product Classification
INGREDIENTS (4)
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
fluocinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0431
Application NumberANDA072488
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2010
FDA Product Classification
INGREDIENTS (6)
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
1,2,6-HEXANETRIOLInactive
Code: W45XXM0XWE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
fluocinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3023
Application NumberANDA072537
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2010
FDA Product Classification
INGREDIENTS (7)
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE BInactive
Code: HHT01ZNK31
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT