NDC 50458-561

INVEGA SUSTENNA

Paliperidone Palmitate

INVEGA SUSTENNA is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Paliperidone Palmitate.

Product ID50458-561_86e7f21e-638b-11ea-8ce6-7c2bfc2ca371
NDC50458-561
Product TypeHuman Prescription Drug
Proprietary NameINVEGA SUSTENNA
Generic NamePaliperidone Palmitate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2009-07-31
Marketing CategoryNDA / NDA
Application NumberNDA022264
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NamePALIPERIDONE PALMITATE
Active Ingredient Strength78 mg/.5mL
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50458-561-01

1 SYRINGE in 1 KIT (50458-561-01) > .5 mL in 1 SYRINGE
Marketing Start Date2009-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-561-01 [50458056101]

INVEGA SUSTENNA INJECTION
Marketing CategoryNDA
Application NumberNDA022264
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-07-31

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE PALMITATE78 mg/.5mL

OpenFDA Data

SPL SET ID:1af14e42-951d-414d-8564-5d5fce138554
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 858057
  • 858074
  • 858051
  • 858052
  • 858053
  • 858054
  • 858055
  • 858056
  • 858048
  • 858073
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    50458056101 INVEGA SUSTENNA 78 MG/0.5 ML

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "INVEGA SUSTENNA" or generic name "Paliperidone Palmitate"

    NDCBrand NameGeneric Name
    50458-560INVEGA SUSTENNApaliperidone palmitate
    50458-561INVEGA SUSTENNApaliperidone palmitate
    50458-562INVEGA SUSTENNApaliperidone palmitate
    50458-563INVEGA SUSTENNApaliperidone palmitate
    50458-564INVEGA SUSTENNApaliperidone palmitate
    50458-606INVEGA TRINZApaliperidone palmitate
    50458-607INVEGA TRINZApaliperidone palmitate
    50458-608INVEGA TRINZApaliperidone palmitate

    Trademark Results [INVEGA SUSTENNA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    INVEGA SUSTENNA
    INVEGA SUSTENNA
    77719232 4272521 Dead/Cancelled
    JOHNSON & JOHNSON
    2009-04-22
    INVEGA SUSTENNA
    INVEGA SUSTENNA
    77408691 3709520 Live/Registered
    Johnson & Johnson
    2008-02-28

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