invega sustenna

Generic: paliperidone palmitate

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

Drug Facts

Product Profile

Brand Name invega sustenna
Generic Name paliperidone palmitate
Labeler janssen pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

paliperidone palmitate 156 mg/mL

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-563
Product ID 50458-563_2e1c43cb-d27e-b3ac-e063-6394a90ad44a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022264
Listing Expiration 2026-12-31
Marketing Start 2009-07-31

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458563
Hyphenated Format 50458-563

Supplemental Identifiers

RxCUI
858048 858051 858052 858053 858054 858055 858056 858057 858073 858074
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 sustenna (source: ndc)
Generic Name paliperidone palmitate (source: ndc)
Application Number NDA022264 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 156 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 KIT (50458-563-01) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 KIT (50458-563-03) / 1 mL in 1 SYRINGE
source: ndc

Packages (2)

50458-563-01 1 SYRINGE in 1 KIT (50458-563-01) / 1 mL in 1 SYRINGE 50458-563-03 1 SYRINGE in 1 KIT (50458-563-03) / 1 mL in 1 SYRINGE

Ingredients (1)

paliperidone palmitate (156 mg/mL)

Linked Drug Pages (1)

INVEGA SUSTENNA ndc-match (0.9)

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"}