Fluocinolone Acetonide
Fluocinolone Acetonide Oil 0.01% (Ear Drops)
Approved
Approval ID
79591576-1eab-48c5-b0a6-e205b3cc097e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2021
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinolone Acetonide Oil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-329
Application NumberANDA203378
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinolone Acetonide Oil
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateOctober 25, 2018
FDA Product Classification
INGREDIENTS (6)
FLUOCINOLONE ACETONIDEActive
Quantity: 0.11 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
OLETH-2Inactive
Code: 7L6R1SQ6M0
Classification: IACT