paliperidone

Generic: paliperidone

Labeler: camber pharmaceuticals, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 1.5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 31722-317
Product ID 31722-317_eef3afa1-f61d-4412-a358-aaa06275985b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216174
Listing Expiration 2026-12-31
Marketing Start 2023-08-23

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722317
Hyphenated Format 31722-317

Supplemental Identifiers

RxCUI
672567 672569 672571 866103
UPC
0331722317306 0331722320306 0331722318303 0331722319300
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 ANDA216174 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-317-30)
source: ndc

Packages (1)

31722-317-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-317-30)

Ingredients (1)

paliperidone (1.5 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": "eef3afa1-f61d-4412-a358-aaa06275985b", "openfda": {"nui": ["N0000175430"], "upc": ["0331722317306", "0331722320306", "0331722318303", "0331722319300"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["1cfcad42-da71-457d-b1e1-aee806642d0c"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-317-30)", "package_ndc": "31722-317-30", "marketing_start_date": "20230823"}], "brand_name": "PALIPERIDONE", "product_id": "31722-317_eef3afa1-f61d-4412-a358-aaa06275985b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "31722-317", "generic_name": "paliperidone", "labeler_name": "Camber Pharmaceuticals, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PALIPERIDONE", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "1.5 mg/1"}], "application_number": "ANDA216174", "marketing_category": "ANDA", "marketing_start_date": "20230823", "listing_expiration_date": "20261231"}