NDC 70518-1867

Fanapt

Iloperidone

Fanapt is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Iloperidone.

Product ID70518-1867_8401cc5f-27dc-79df-e053-2a91aa0af04d
NDC70518-1867
Product TypeHuman Prescription Drug
Proprietary NameFanapt
Generic NameIloperidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-02-13
Marketing CategoryNDA / NDA
Application NumberNDA022192
Labeler NameREMEDYREPACK INC.
Substance NameILOPERIDONE
Active Ingredient Strength8 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1867-0

30 POUCH in 1 BOX, UNIT-DOSE (70518-1867-0) > 1 TABLET in 1 POUCH (70518-1867-1)
Marketing Start Date2019-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1867-0 [70518186700]

Fanapt TABLET
Marketing CategoryNDA
Application NumberNDA022192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

NDC 70518-1867-1 [70518186701]

Fanapt TABLET
Marketing CategoryNDA
Application NumberNDA022192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-13

Drug Details

Active Ingredients

IngredientStrength
ILOPERIDONE8 mg/1

OpenFDA Data

SPL SET ID:51d49586-e554-4b2e-9d22-7d9048eecacb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 848748
  • 848750

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • 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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