NDC 69189-0597

FANAPT

Iloperidone

FANAPT is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Iloperidone.

Product ID69189-0597_0e466fcb-7c75-4bb6-bcf1-f4d2451e8190
NDC69189-0597
Product TypeHuman Prescription Drug
Proprietary NameFANAPT
Generic NameIloperidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-06-02
Marketing CategoryNDA / NDA
Application NumberNDA022192
Labeler NameAvera McKennan Hospital
Substance NameILOPERIDONE
Active Ingredient Strength4 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69189-0597-1

1 TABLET in 1 DOSE PACK (69189-0597-1)
Marketing Start Date2015-06-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69189-0597-1 [69189059701]

FANAPT TABLET
Marketing CategoryNDA
Application NumberNDA022192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ILOPERIDONE4 mg/1

OpenFDA Data

SPL SET ID:b414d51b-9e4d-4045-bf29-108be5327e00
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 848740
  • 848742

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "FANAPT" or generic name "Iloperidone"

    NDCBrand NameGeneric Name
    43068-101Fanaptiloperidone
    43068-102Fanaptiloperidone
    43068-104Fanaptiloperidone
    43068-106Fanaptiloperidone
    43068-108Fanaptiloperidone
    43068-110Fanaptiloperidone
    43068-112Fanaptiloperidone
    43068-113Fanaptiloperidone
    43068-901Fanaptiloperidone
    43068-902Fanaptiloperidone
    43068-903Fanaptiloperidone
    69189-0597FANAPTIloperidone
    69189-0665Fanaptiloperidone
    70518-1867Fanaptiloperidone
    0378-0630IloperidoneIloperidone
    0378-0631IloperidoneIloperidone
    0378-0632IloperidoneIloperidone
    0378-0633IloperidoneIloperidone
    0378-0634IloperidoneIloperidone
    0378-0635IloperidoneIloperidone
    0378-0636IloperidoneIloperidone
    51672-4178IloperidoneIloperidone
    51672-4179IloperidoneIloperidone
    51672-4180IloperidoneIloperidone
    51672-4181IloperidoneIloperidone
    51672-4182IloperidoneIloperidone
    51672-4183IloperidoneIloperidone
    51672-4184IloperidoneIloperidone
    51672-4213IloperidoneIloperidone

    Trademark Results [FANAPT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FANAPT
    FANAPT
    77512787 3870927 Live/Registered
    Vanda Pharmaceuticals Inc.
    2008-07-01
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