paliperidone

Generic: paliperidone

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

Drug Facts

Product Profile

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

paliperidone 9 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-526
Product ID 68180-526_1f2a8fc9-461e-4e33-9a00-81caf2fcd973
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208643
Marketing Start 2022-10-19
Marketing End 2026-03-31

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180526
Hyphenated Format 68180-526

Supplemental Identifiers

RxCUI
672567 672569 672571 866103
UPC
0368180526063 0368180525066 0368180524069 0368180523062
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 ANDA208643 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-526-06)
source: ndc

Packages (1)

68180-526-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-526-06)

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": "1f2a8fc9-461e-4e33-9a00-81caf2fcd973", "openfda": {"nui": ["N0000175430"], "upc": ["0368180526063", "0368180525066", "0368180524069", "0368180523062"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["f30421f7-63d1-4800-99f5-479f2ca336be"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-526-06)", "package_ndc": "68180-526-06", "marketing_end_date": "20260331", "marketing_start_date": "20221019"}], "brand_name": "Paliperidone", "product_id": "68180-526_1f2a8fc9-461e-4e33-9a00-81caf2fcd973", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68180-526", "generic_name": "Paliperidone", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paliperidone", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "9 mg/1"}], "application_number": "ANDA208643", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20221019"}