NDC 50458-608

INVEGA TRINZA

Paliperidone Palmitate

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

Product ID50458-608_1ef256dc-8107-11eb-98e1-81dffb2ca371
NDC50458-608
Product TypeHuman Prescription Drug
Proprietary NameINVEGA TRINZA
Generic NamePaliperidone Palmitate
Dosage FormInjection, Suspension, Extended Release
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2015-05-19
Marketing CategoryNDA / NDA
Application NumberNDA207946
Labeler NameJanssen Pharmaceuticals, Inc
Substance NamePALIPERIDONE PALMITATE
Active Ingredient Strength546 mg/1.75mL
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50458-608-01

1 SYRINGE in 1 KIT (50458-608-01) > 1 mL in 1 SYRINGE
Marketing Start Date2015-05-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-608-01 [50458060801]

INVEGA TRINZA INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA207946
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-05-19

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE PALMITATE546 mg/1.75mL

OpenFDA Data

SPL SET ID:c39e65d7-fa44-4e4c-8b12-a654d3ed0eae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1650968
  • 1650975
  • 1650974
  • 1650976
  • 1650971
  • 1650973
  • 1650972
  • 1650966
  • Pharmacological Class

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

    Medicade Reported Pricing

    50458060801 INVEGA TRINZA 546 MG/1.75 ML

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    50458-606INVEGA TRINZApaliperidone palmitate
    50458-607INVEGA TRINZApaliperidone palmitate
    50458-608INVEGA TRINZApaliperidone palmitate
    50458-609INVEGA TRINZAINVEGA TRINZA
    50458-560INVEGA SUSTENNApaliperidone palmitate
    50458-561INVEGA SUSTENNApaliperidone palmitate
    50458-562INVEGA SUSTENNApaliperidone palmitate
    50458-563INVEGA SUSTENNApaliperidone palmitate
    50458-564INVEGA SUSTENNApaliperidone palmitate

    Trademark Results [INVEGA TRINZA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    INVEGA TRINZA
    INVEGA TRINZA
    86500977 4838342 Live/Registered
    JOHNSON & JOHNSON
    2015-01-12

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