paliperidone

Generic: paliperidone

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 3 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-916
Product ID 42291-916_48bf98f0-9cf7-351e-e063-6394a90ab72b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204707
Listing Expiration 2027-12-31
Marketing Start 2023-07-28

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291916
Hyphenated Format 42291-916

Supplemental Identifiers

RxCUI
672567 672569 672571 866103
UPC
0342291917309 0342291918306 0342291916302 0342291915305
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 BOTTLE (42291-916-30)
source: ndc

Packages (1)

42291-916-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-916-30)

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": "48bf98f0-9cf7-351e-e063-6394a90ab72b", "openfda": {"nui": ["N0000175430"], "upc": ["0342291917309", "0342291918306", "0342291916302", "0342291915305"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["018cf3ca-bee9-23a6-e063-6394a90ad905"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-916-30)", "package_ndc": "42291-916-30", "marketing_start_date": "20230728"}], "brand_name": "Paliperidone", "product_id": "42291-916_48bf98f0-9cf7-351e-e063-6394a90ab72b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "42291-916", "generic_name": "Paliperidone", "labeler_name": "AvKARE", "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": "20230728", "listing_expiration_date": "20271231"}