paliperidone

Generic: paliperidone

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 3 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43975-350
Product ID 43975-350_338098af-3cc9-1639-e063-6394a90a6550
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204452
Listing Expiration 2026-12-31
Marketing Start 2019-11-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43975350
Hyphenated Format 43975-350

Supplemental Identifiers

RxCUI
672567 672569 672571 866103
UPC
0343975352034 0343975350030 0343975349034 0343975351037
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 ANDA204452 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03)
source: ndc

Packages (1)

43975-350-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03)

Ingredients (1)

paliperidone (3 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": "338098af-3cc9-1639-e063-6394a90a6550", "openfda": {"nui": ["N0000175430"], "upc": ["0343975352034", "0343975350030", "0343975349034", "0343975351037"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["bbbaa057-f587-4eb9-a0d2-463dbcd57661"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03)", "package_ndc": "43975-350-03", "marketing_start_date": "20191127"}], "brand_name": "PALIPERIDONE", "product_id": "43975-350_338098af-3cc9-1639-e063-6394a90a6550", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43975-350", "generic_name": "PALIPERIDONE", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PALIPERIDONE", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "3 mg/1"}], "application_number": "ANDA204452", "marketing_category": "ANDA", "marketing_start_date": "20191127", "listing_expiration_date": "20261231"}