NDC 50458-554

INVEGA

Paliperidone

INVEGA is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Paliperidone.

Product ID50458-554_25b1fbca-09c7-11ea-b666-8f2d192adfa6
NDC50458-554
Product TypeHuman Prescription Drug
Proprietary NameINVEGA
Generic NamePaliperidone
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-09-10
Marketing CategoryNDA / NDA
Application NumberNDA021999
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NamePALIPERIDONE
Active Ingredient Strength2 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50458-554-01

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-554-01)
Marketing Start Date2009-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-554-10 [50458055410]

INVEGA TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-10

NDC 50458-554-98 [50458055498]

INVEGA TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-10
Marketing End Date2017-06-28

NDC 50458-554-01 [50458055401]

INVEGA TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-09-10

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE1.5 mg/1

OpenFDA Data

SPL SET ID:7b8e5b26-b9e4-4704-921b-3c3c0d159916
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 672567
  • 686445
  • 672571
  • 686443
  • 686441
  • 866103
  • 866105
  • 672569
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    50458055401 INVEGA ER 1.5 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    21695-455INVEGAINVEGA
    50458-552INVEGAINVEGA
    50458-554INVEGAINVEGA
    50458-550INVEGAINVEGA
    50458-551INVEGAINVEGA
    64725-0550INVEGAINVEGA
    0378-3978Paliperidonepaliperidone
    0378-3979Paliperidonepaliperidone
    0378-3980Paliperidonepaliperidone
    0378-3981Paliperidonepaliperidone
    0591-3692PaliperidonePaliperidone
    0591-3693PaliperidonePaliperidone
    0591-3694PaliperidonePaliperidone
    0591-3695PaliperidonePaliperidone
    0904-6935PaliperidonePaliperidone
    0904-6936PaliperidonePaliperidone
    0904-6937PaliperidonePaliperidone
    10147-0951Paliperidonepaliperidone
    10147-0952Paliperidonepaliperidone
    10147-0953Paliperidonepaliperidone

    Trademark Results [INVEGA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    INVEGA
    INVEGA
    77239338 3391680 Live/Registered
    Johnson & Johnson
    2007-07-26
    INVEGA
    INVEGA
    76650290 3344746 Live/Registered
    JOHNSON & JOHNSON
    2005-11-14

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