Package 50458-611-01

Brand: invega hafyera

Generic: paliperidone palmitate
NDC Package

Package Facts

Identity

Package NDC 50458-611-01
Digits Only 5045861101
Product NDC 50458-611
Description

1 SYRINGE in 1 CARTON (50458-611-01) / 3.5 mL in 1 SYRINGE

Marketing

Marketing Status
Marketed Since 2021-08-30
Brand invega hafyera
Generic paliperidone palmitate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR"], "spl_id": "2e6ef0e1-19d2-7d78-e063-6394a90ae8a6", "openfda": {"unii": ["R8P8USM8FR"], "rxcui": ["2570418", "2570419", "2570420", "2570421"], "spl_set_id": ["6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (50458-611-01)  / 3.5 mL in 1 SYRINGE", "package_ndc": "50458-611-01", "marketing_start_date": "20210830"}], "brand_name": "INVEGA HAFYERA", "product_id": "50458-611_2e6ef0e1-19d2-7d78-e063-6394a90ae8a6", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50458-611", "generic_name": "paliperidone palmitate", "labeler_name": "Janssen Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INVEGA HAFYERA", "active_ingredients": [{"name": "PALIPERIDONE PALMITATE", "strength": "1092 mg/3.5mL"}], "application_number": "NDA207946", "marketing_category": "NDA", "marketing_start_date": "20210830", "listing_expiration_date": "20261231"}