invega

Generic: paliperidone

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

Drug Facts

Product Profile

Brand Name invega
Generic Name paliperidone
Labeler janssen pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paliperidone 3 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-550
Product ID 50458-550_2d7fc88e-1b20-313c-e063-6394a90ac22b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021999
Listing Expiration 2026-12-31
Marketing Start 2006-12-19

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458550
Hyphenated Format 50458-550

Supplemental Identifiers

RxCUI
672567 672569 672571 686441 686443 686445 866103 866105
UNII
838F01T721
NUI
N0000175430

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 (source: ndc)
Generic Name paliperidone (source: ndc)
Application Number NDA021999 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01)
  • 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-98)
source: ndc

Packages (2)

50458-550-01 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01) 50458-550-98 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-98)

Ingredients (1)

paliperidone (3 mg/1)

Linked Drug Pages (1)

INVEGA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d7fc88e-1b20-313c-e063-6394a90ac22b", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "686441", "686443", "686445", "866103", "866105"], "spl_set_id": ["7b8e5b26-b9e4-4704-921b-3c3c0d159916"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01)", "package_ndc": "50458-550-01", "marketing_start_date": "20061219"}, {"sample": true, "description": "7 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-98)", "package_ndc": "50458-550-98", "marketing_start_date": "20061219"}], "brand_name": "INVEGA", "product_id": "50458-550_2d7fc88e-1b20-313c-e063-6394a90ac22b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50458-550", "generic_name": "paliperidone", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INVEGA", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "3 mg/1"}], "application_number": "NDA021999", "marketing_category": "NDA", "marketing_start_date": "20061219", "listing_expiration_date": "20261231"}