Package 50458-564-01
Brand: invega sustenna
Generic: paliperidone palmitatePackage Facts
Identity
Package NDC
50458-564-01
Digits Only
5045856401
Product NDC
50458-564
Description
1 SYRINGE in 1 KIT (50458-564-01) / 1.5 mL in 1 SYRINGE
Marketing
Marketing Status
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 (50458-564-01) / 1.5 mL in 1 SYRINGE", "package_ndc": "50458-564-01", "marketing_start_date": "20090731"}, {"sample": true, "description": "1 SYRINGE in 1 KIT (50458-564-03) / 1.5 mL in 1 SYRINGE", "package_ndc": "50458-564-03", "marketing_start_date": "20090731"}], "brand_name": "INVEGA SUSTENNA", "product_id": "50458-564_2e1c43cb-d27e-b3ac-e063-6394a90ad44a", "dosage_form": "INJECTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50458-564", "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": "234 mg/1.5mL"}], "application_number": "NDA022264", "marketing_category": "NDA", "marketing_start_date": "20090731", "listing_expiration_date": "20261231"}