paliperidone

Generic: paliperidone

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paliperidone
Generic Name paliperidone
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paliperidone 1.5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-280
Product ID 65162-280_d01cb993-8ed1-4746-ad80-d95d3025c3ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204707
Listing Expiration 2026-12-31
Marketing Start 2019-09-24

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162280
Hyphenated Format 65162-280

Supplemental Identifiers

RxCUI
672567 672569 672571 866103
UPC
0365162280036 0365162282030 0365162281033 0365162283037
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 ANDA204707 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-280-03)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-280-09)
source: ndc

Packages (2)

65162-280-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-280-03) 65162-280-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-280-09)

Ingredients (1)

paliperidone (1.5 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": "d01cb993-8ed1-4746-ad80-d95d3025c3ac", "openfda": {"nui": ["N0000175430"], "upc": ["0365162280036", "0365162282030", "0365162281033", "0365162283037"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["7b269778-803b-4ce2-a8c0-636fb131d16a"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-280-03)", "package_ndc": "65162-280-03", "marketing_start_date": "20190924"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-280-09)", "package_ndc": "65162-280-09", "marketing_start_date": "20190924"}], "brand_name": "Paliperidone", "product_id": "65162-280_d01cb993-8ed1-4746-ad80-d95d3025c3ac", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65162-280", "generic_name": "Paliperidone", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paliperidone", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "1.5 mg/1"}], "application_number": "ANDA204707", "marketing_category": "ANDA", "marketing_start_date": "20190924", "listing_expiration_date": "20261231"}