Package 50458-563-01

Brand: invega sustenna

Generic: paliperidone palmitate
NDC Package

Package Facts

Identity

Package NDC 50458-563-01
Digits Only 5045856301
Product NDC 50458-563
Description

1 SYRINGE in 1 KIT (50458-563-01) / 1 mL in 1 SYRINGE

Marketing

Marketing Status
Marketed Since 2009-07-31
Brand invega sustenna
Generic paliperidone palmitate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR"], "spl_id": "2e1c43cb-d27e-b3ac-e063-6394a90ad44a", "openfda": {"unii": ["R8P8USM8FR"], "rxcui": ["858048", "858051", "858052", "858053", "858054", "858055", "858056", "858057", "858073", "858074"], "spl_set_id": ["1af14e42-951d-414d-8564-5d5fce138554"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 KIT (50458-563-01)  / 1 mL in 1 SYRINGE", "package_ndc": "50458-563-01", "marketing_start_date": "20090731"}, {"sample": true, "description": "1 SYRINGE in 1 KIT (50458-563-03)  / 1 mL in 1 SYRINGE", "package_ndc": "50458-563-03", "marketing_start_date": "20090731"}], "brand_name": "INVEGA SUSTENNA", "product_id": "50458-563_2e1c43cb-d27e-b3ac-e063-6394a90ad44a", "dosage_form": "INJECTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50458-563", "generic_name": "paliperidone palmitate", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INVEGA SUSTENNA", "active_ingredients": [{"name": "PALIPERIDONE PALMITATE", "strength": "156 mg/mL"}], "application_number": "NDA022264", "marketing_category": "NDA", "marketing_start_date": "20090731", "listing_expiration_date": "20261231"}