Fluocinonide
Fluocinonide Cream, USP 0.05% (Emulsified Base) For External Use Only Not for Ophthalmic Use Rx only
Approved
Approval ID
c229433a-a630-8f9a-8b8c-762ab7e1dd81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2016
Manufacturers
FDA
Impax Generics
DUNS: 079832487
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 Code0115-1706
Application NumberANDA074204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 25, 2016
FDA Product Classification
INGREDIENTS (9)
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sorbitan MonostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Fluocinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1705
Application NumberANDA074204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 25, 2016
FDA Product Classification
INGREDIENTS (9)
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sorbitan MonostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Fluocinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1707
Application NumberANDA074204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 25, 2016
FDA Product Classification
INGREDIENTS (9)
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sorbitan MonostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT