NDC 12496-0090

PERSERIS

Risperidone

PERSERIS is a Subcutaneous Kit in the Human Prescription Drug category. It is labeled and distributed by Indivior Inc.. The primary component is .

Product ID12496-0090_05359404-1ba2-4e9d-90c2-798874ab4106
NDC12496-0090
Product TypeHuman Prescription Drug
Proprietary NamePERSERIS
Generic NameRisperidone
Dosage FormKit
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-11-09
Marketing CategoryNDA / NDA
Application NumberNDA210655
Labeler NameIndivior Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 12496-0090-1

1 KIT in 1 CARTON (12496-0090-1) * 1 SYRINGE in 1 POUCH > 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (12496-0589-2) > 1 mL in 1 SYRINGE (12496-0589-5)
Marketing Start Date2018-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12496-0090-9 [12496009009]

PERSERIS KIT
Marketing CategoryNDA
Application NumberNDA210655
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-12

NDC 12496-0090-1 [12496009001]

PERSERIS KIT
Marketing CategoryNDA
Application NumberNDA210655
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-09

Drug Details

OpenFDA Data

SPL SET ID:a4f21b1a-5691-4b14-a56d-651962d06f39
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 2055672
  • 2055667
  • 2055675
  • 2055676

    • NDC Crossover Matching brand name "PERSERIS" or generic name "Risperidone"

    NDCBrand NameGeneric Name
    12496-0090PERSERISPERSERIS
    12496-0120PERSERISPERSERIS
    0054-0063RisperidoneRisperidone
    0378-3502Risperidonerisperidone
    0378-3505Risperidonerisperidone
    0378-3511Risperidonerisperidone
    0378-3512Risperidonerisperidone
    0378-3513Risperidonerisperidone
    0378-3514Risperidonerisperidone
    0603-9424RisperidoneRisperidone
    0615-7505Risperidonerisperidone
    0615-7506Risperidonerisperidone
    0615-7507Risperidonerisperidone
    0615-8196RisperidoneRisperidone
    0615-8197RisperidoneRisperidone
    0615-8198RisperidoneRisperidone
    0615-8265RisperidoneRisperidone
    0615-8288RisperidoneRisperidone
    0781-5310RisperidoneRisperidone
    0781-5311RisperidoneRisperidone
    0781-5312RisperidoneRisperidone
    0781-5313RisperidoneRisperidone

    Trademark Results [PERSERIS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PERSERIS
    PERSERIS
    86892714 5715849 Live/Registered
    Indivior UK Limited
    2016-02-01
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