paliperidone

Generic: paliperidone

Labeler: eskayef pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 3 mg/1

Manufacturer
Eskayef Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 72658-1254
Product ID 72658-1254_3e4a14d9-8d90-5f05-e063-6294a90a110e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218755
Listing Expiration 2026-12-31
Marketing Start 2025-10-02

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 726581254
Hyphenated Format 72658-1254

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 ANDA218755 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-1)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-2)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-3)
source: ndc

Packages (3)

72658-1254-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-1) 72658-1254-2 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-2) 72658-1254-3 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-3)

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": "3e4a14d9-8d90-5f05-e063-6294a90a110e", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["de95e29f-a030-4777-a601-874500ab8e91"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Eskayef Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-1)", "package_ndc": "72658-1254-1", "marketing_start_date": "20251002"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-2)", "package_ndc": "72658-1254-2", "marketing_start_date": "20251002"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-3)", "package_ndc": "72658-1254-3", "marketing_start_date": "20251002"}], "brand_name": "PALIPERIDONE", "product_id": "72658-1254_3e4a14d9-8d90-5f05-e063-6294a90a110e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72658-1254", "generic_name": "PALIPERIDONE", "labeler_name": "Eskayef Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PALIPERIDONE", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "3 mg/1"}], "application_number": "ANDA218755", "marketing_category": "ANDA", "marketing_start_date": "20251002", "listing_expiration_date": "20261231"}