invega trinza

Generic: paliperidone palmitate

Labeler: janssen pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name invega trinza
Generic Name paliperidone palmitate
Labeler janssen pharmaceuticals, inc
Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
INTRAMUSCULAR
Active Ingredients

paliperidone palmitate 410 mg/1.32mL

Manufacturer
Janssen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50458-607
Product ID 50458-607_2e1c6fa0-3051-4a53-e063-6294a90ad1c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207946
Listing Expiration 2026-12-31
Marketing Start 2015-05-19

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458607
Hyphenated Format 50458-607

Supplemental Identifiers

RxCUI
1650966 1650968 1650971 1650972 1650973 1650974 1650975 1650976
UNII
R8P8USM8FR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name invega trinza (source: ndc)
Generic Name paliperidone palmitate (source: ndc)
Application Number NDA207946 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 410 mg/1.32mL
source: ndc
Packaging
  • 1 SYRINGE in 1 KIT (50458-607-01) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

50458-607-01 1 SYRINGE in 1 KIT (50458-607-01) / 1 mL in 1 SYRINGE

Ingredients (1)

paliperidone palmitate (410 mg/1.32mL)

Linked Drug Pages (1)

INVEGA TRINZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "2e1c6fa0-3051-4a53-e063-6294a90ad1c3", "openfda": {"unii": ["R8P8USM8FR"], "rxcui": ["1650966", "1650968", "1650971", "1650972", "1650973", "1650974", "1650975", "1650976"], "spl_set_id": ["c39e65d7-fa44-4e4c-8b12-a654d3ed0eae"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 KIT (50458-607-01)  / 1 mL in 1 SYRINGE", "package_ndc": "50458-607-01", "marketing_start_date": "20150519"}], "brand_name": "INVEGA TRINZA", "product_id": "50458-607_2e1c6fa0-3051-4a53-e063-6294a90ad1c3", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50458-607", "generic_name": "paliperidone palmitate", "labeler_name": "Janssen Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INVEGA TRINZA", "active_ingredients": [{"name": "PALIPERIDONE PALMITATE", "strength": "410 mg/1.32mL"}], "application_number": "NDA207946", "marketing_category": "NDA", "marketing_start_date": "20150519", "listing_expiration_date": "20261231"}