Fluocinonide Gel
Fluocinonide Gel
Approved
Approval ID
3bd220d7-9a5a-3341-6bd5-619387267200
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 18, 2023
Manufacturers
FDA
Alvogen Inc.
DUNS: 008057330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinonide Gel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47781-533
Application NumberNDA017373
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluocinonide Gel
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2015
FDA Product Classification
INGREDIENTS (7)
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Propyl GallateInactive
Code: 8D4SNN7V92
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT