paliperidone

Generic: paliperidone

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 9 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4267
Product ID 70518-4267_400ab61f-5daf-6925-e063-6394a90ae1f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205618
Listing Expiration 2026-12-31
Marketing Start 2025-01-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184267
Hyphenated Format 70518-4267

Supplemental Identifiers

RxCUI
672571
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 ANDA205618 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4267-0)
  • 30 POUCH in 1 BOX (70518-4267-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4267-2)
source: ndc

Packages (2)

70518-4267-0 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4267-0) 70518-4267-1 30 POUCH in 1 BOX (70518-4267-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4267-2)

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": "400ab61f-5daf-6925-e063-6394a90ae1f6", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672571"], "spl_set_id": ["f13d3678-a861-42ba-be44-0d89f1b66ef3"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4267-0)", "package_ndc": "70518-4267-0", "marketing_start_date": "20250127"}, {"sample": false, "description": "30 POUCH in 1 BOX (70518-4267-1)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4267-2)", "package_ndc": "70518-4267-1", "marketing_start_date": "20250128"}], "brand_name": "Paliperidone", "product_id": "70518-4267_400ab61f-5daf-6925-e063-6394a90ae1f6", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-4267", "generic_name": "Paliperidone", "labeler_name": "REMEDYREPACK 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": "20250127", "listing_expiration_date": "20261231"}