paliperidone

Generic: paliperidone

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 6 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-278
Product ID 27241-278_96765b43-a41f-4bba-a582-0e130e813ad3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218514
Listing Expiration 2026-12-31
Marketing Start 2024-06-26

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241278
Hyphenated Format 27241-278

Supplemental Identifiers

RxCUI
672567 672569 672571 866103
UPC
0327241277306 0327241276309 0327241279300 0327241278303
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 ANDA218514 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-278-30)
source: ndc

Packages (1)

27241-278-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-278-30)

Ingredients (1)

paliperidone (6 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": "96765b43-a41f-4bba-a582-0e130e813ad3", "openfda": {"nui": ["N0000175430"], "upc": ["0327241277306", "0327241276309", "0327241279300", "0327241278303"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["71985eb4-07df-41c9-8b9a-85f39e92b7d0"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-278-30)", "package_ndc": "27241-278-30", "marketing_start_date": "20240626"}], "brand_name": "Paliperidone", "product_id": "27241-278_96765b43-a41f-4bba-a582-0e130e813ad3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "27241-278", "generic_name": "Paliperidone", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Paliperidone", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "6 mg/1"}], "application_number": "ANDA218514", "marketing_category": "ANDA", "marketing_start_date": "20240626", "listing_expiration_date": "20261231"}