paliperidone

Generic: paliperidone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name paliperidone
Generic Name paliperidone
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

paliperidone 9 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-767
Product ID 47335-767_ee4f515b-499a-499d-aece-50a4aeb0aae9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205618
Listing Expiration 2026-12-31
Marketing Start 2018-08-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335767
Hyphenated Format 47335-767

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 ANDA205618 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-767-83)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-767-88)
source: ndc

Packages (2)

47335-767-83 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-767-83) 47335-767-88 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-767-88)

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": "ee4f515b-499a-499d-aece-50a4aeb0aae9", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["0dc3a9b2-2edf-4fa2-a949-459b4218e763"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-767-83)", "package_ndc": "47335-767-83", "marketing_start_date": "20180801"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-767-88)", "package_ndc": "47335-767-88", "marketing_start_date": "20180801"}], "brand_name": "Paliperidone", "product_id": "47335-767_ee4f515b-499a-499d-aece-50a4aeb0aae9", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "47335-767", "generic_name": "Paliperidone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paliperidone", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "9 mg/1"}], "application_number": "ANDA205618", "marketing_category": "ANDA", "marketing_start_date": "20180801", "listing_expiration_date": "20261231"}