NDC 50458-551

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 ID50458-551_25b1fbca-09c7-11ea-b666-8f2d192adfa6
NDC50458-551
Product TypeHuman Prescription Drug
Proprietary NameINVEGA
Generic NamePaliperidone
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-12-19
Marketing CategoryNDA / NDA
Application NumberNDA021999
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NamePALIPERIDONE
Active Ingredient Strength6 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50458-551-01

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-551-01)
Marketing Start Date2006-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-551-01 [50458055101]

INVEGA TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-19

NDC 50458-551-02 [50458055102]

INVEGA TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-19
Marketing End Date2009-10-01

NDC 50458-551-10 [50458055110]

INVEGA TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-19

NDC 50458-551-98 [50458055198]

INVEGA TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-19

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE6 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

    50458055110 INVEGA ER 6 MG TABLET

    Pricing Unit: EA | Drug Type:

    50458055101 INVEGA ER 6 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.