paliperidone

Generic: paliperidone

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 3 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1539
Product ID 67046-1539_31352593-a65e-3b4e-e063-6294a90a49f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204707
Listing Expiration 2026-12-31
Marketing Start 2025-03-25

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461539
Hyphenated Format 67046-1539

Supplemental Identifiers

RxCUI
672567
UNII
838F01T721
NUI
N0000175430

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
  • 3 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1539-3)
source: ndc

Packages (1)

67046-1539-3 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1539-3)

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": "31352593-a65e-3b4e-e063-6294a90a49f9", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672567"], "spl_set_id": ["313538c9-01d3-1558-e063-6394a90aa21d"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1539-3)", "package_ndc": "67046-1539-3", "marketing_start_date": "20250325"}], "brand_name": "Paliperidone", "product_id": "67046-1539_31352593-a65e-3b4e-e063-6294a90a49f9", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67046-1539", "generic_name": "Paliperidone", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paliperidone", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "3 mg/1"}], "application_number": "ANDA204707", "marketing_category": "ANDA", "marketing_start_date": "20250325", "listing_expiration_date": "20261231"}