paliperidone

Generic: paliperidone

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paliperidone
Generic Name paliperidone
Labeler viona pharmaceuticals inc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paliperidone 9 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-193
Product ID 72578-193_627d9ff9-9d42-4c02-b67d-6de17177cb1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217445
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578193
Hyphenated Format 72578-193

Supplemental Identifiers

RxCUI
672567 672569 672571 866103
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 paliperidone (source: ndc)
Generic Name paliperidone (source: ndc)
Application Number ANDA217445 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-05)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-06)
source: ndc

Packages (3)

72578-193-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-01) 72578-193-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-05) 72578-193-06 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-06)

Ingredients (1)

paliperidone (9 mg/1)

Linked Drug Pages (1)

Paliperidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "627d9ff9-9d42-4c02-b67d-6de17177cb1a", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["163898a4-6088-46a0-9253-dd9187c557be"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-01)", "package_ndc": "72578-193-01", "marketing_start_date": "20250601"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-05)", "package_ndc": "72578-193-05", "marketing_start_date": "20250601"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72578-193-06)", "package_ndc": "72578-193-06", "marketing_start_date": "20250601"}], "brand_name": "Paliperidone", "product_id": "72578-193_627d9ff9-9d42-4c02-b67d-6de17177cb1a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72578-193", "generic_name": "Paliperidone", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paliperidone", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "9 mg/1"}], "application_number": "ANDA217445", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}