NDC 68611-190

Iluvien

Fluocinolone Acetonide

Iluvien is a Intravitreal Implant in the Human Prescription Drug category. It is labeled and distributed by Alimera Sciences, Inc.. The primary component is Fluocinolone Acetonide.

Product ID68611-190_2e588bc5-1fb2-42a6-bfed-a4d847245bed
NDC68611-190
Product TypeHuman Prescription Drug
Proprietary NameIluvien
Generic NameFluocinolone Acetonide
Dosage FormImplant
Route of AdministrationINTRAVITREAL
Marketing Start Date2014-10-15
Marketing CategoryNDA / NDA
Application NumberNDA201923
Labeler NameAlimera Sciences, Inc.
Substance NameFLUOCINOLONE ACETONIDE
Active Ingredient Strength0 mg/1
Pharm ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68611-190-02

1 TRAY in 1 CARTON (68611-190-02) > 1 APPLICATOR in 1 TRAY > 1 IMPLANT in 1 APPLICATOR
Marketing Start Date2014-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68611-190-02 [68611019002]

Iluvien IMPLANT
Marketing CategoryNDA
Application NumberNDA201923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-15

Drug Details

Active Ingredients

IngredientStrength
FLUOCINOLONE ACETONIDE.19 mg/1

OpenFDA Data

SPL SET ID:4400e471-7402-11df-93f2-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1552351
  • 1552356

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Iluvien" or generic name "Fluocinolone Acetonide"

    NDCBrand NameGeneric Name
    68611-190IluvienIluvien
    0299-5500Capexfluocinolone acetonide
    39328-079Flac Otic Oilfluocinolone acetonide
    0168-0058Fluocinolone Acetonidefluocinolone acetonide
    0168-0059Fluocinolone Acetonidefluocinolone acetonide
    0168-0060Fluocinolone Acetonidefluocinolone acetonide
    0168-0064Fluocinolone Acetonidefluocinolone acetonide
    0713-0223Fluocinolone AcetonideFluocinolone Acetonide
    0713-0224Fluocinolone AcetonideFluocinolone Acetonide
    0713-0324Fluocinolone AcetonideFluocinolone Acetonide
    0713-0325Fluocinolone AcetonideFluocinolone Acetonide
    0713-0709FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDE
    10135-670fluocinolone acetonidefluocinolone acetonide
    13925-506Fluocinolone Acetonidefluocinolone acetonide
    13925-507Fluocinolone Acetonidefluocinolone acetonide
    42291-283Fluocinolone AcetonideFluocinolone Acetonide
    42291-284Fluocinolone AcetonideFluocinolone Acetonide
    42291-285Fluocinolone AcetonideFluocinolone Acetonide
    43386-069Fluocinolone AcetonideFluocinolone Acetonide
    13925-508Fluocinolone acetonide 0.01%fluocinolone acetonide
    24208-416RetisertFluocinolone Acetonide
    43538-900Synalarfluocinolone acetonide
    43538-901SynalarFluocinolone acetonide
    43538-910Synalarfluocinolone acetonide
    43538-911SynalarFluocinolone acetonide
    43538-920Synalarfluocinolone acetonide
    43538-921Synalar TSfluocinolone acetonide

    Trademark Results [Iluvien]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ILUVIEN
    ILUVIEN
    86375920 4805342 Live/Registered
    Alimera Sciences, Inc.
    2014-08-25
    ILUVIEN
    ILUVIEN
    85554862 4393220 Live/Registered
    Alimera Sciences, Inc.
    2012-02-28
    ILUVIEN
    ILUVIEN
    85236699 not registered Dead/Abandoned
    Alimera Sciences, Inc.
    2011-02-08
    ILUVIEN
    ILUVIEN
    77561097 not registered Dead/Abandoned
    Alimera Sciences, Inc.
    2008-09-03
    ILUVIEN
    ILUVIEN
    77162736 4045625 Live/Registered
    Alimera Sciences, Inc.
    2007-04-23
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