Fluocinonide
FLUOCINONIDE OINTMENT USP, 0.05%FOR TOPICAL/EXTERNAL USE ONLYNOT FOR OPHTHALMIC USERx only
Approved
Approval ID
b4b09d4a-dbe9-4f41-ac04-d4f71743722f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2011
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 Code21695-979
Application NumberANDA073481
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2009
FDA Product Classification
INGREDIENTS (3)
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT