invega hafyera

Generic: paliperidone palmitate

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

Drug Facts

Product Profile

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

paliperidone palmitate 1092 mg/3.5mL

Manufacturer
Janssen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50458-611
Product ID 50458-611_2e6ef0e1-19d2-7d78-e063-6394a90ae8a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207946
Listing Expiration 2026-12-31
Marketing Start 2021-08-30

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458611
Hyphenated Format 50458-611

Supplemental Identifiers

RxCUI
2570418 2570419 2570420 2570421
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 hafyera (source: ndc)
Generic Name paliperidone palmitate (source: ndc)
Application Number NDA207946 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 1092 mg/3.5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (50458-611-01) / 3.5 mL in 1 SYRINGE
source: ndc

Packages (1)

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

Ingredients (1)

paliperidone palmitate (1092 mg/3.5mL)

Linked Drug Pages (1)

INVEGA HAFYERA ndc-match (0.9)

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"}