Fluocinonide
Fluocinonide Cream USP, 0.05% Fluocinonide Cream USP, 0.05% (Emulsified Base) Fluocinonide Gel USP, 0.05% Fluocinonide Ointment USP, 0.05%
Approved
Approval ID
09ba89a0-3b29-4cbe-8ff6-1d2487b95caf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-207
Application NumberANDA019117
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 3, 2008
FDA Product Classification
INGREDIENTS (8)
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
1,2,6-hexanetriolInactive
Code: W45XXM0XWE
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
citric acidInactive
Code: 2968PHW8QP
Classification: IACT