paliperidone

Generic: paliperidone

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 9 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6937
Product ID 0904-6937_23d1a15a-1ba9-46a2-9851-25a00475c0a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205618
Listing Expiration 2026-12-31
Marketing Start 2018-08-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046937
Hyphenated Format 0904-6937

Supplemental Identifiers

RxCUI
672567 672569 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
  • 100 BLISTER PACK in 1 CARTON (0904-6937-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6937-61 100 BLISTER PACK in 1 CARTON (0904-6937-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "23d1a15a-1ba9-46a2-9851-25a00475c0a3", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571"], "spl_set_id": ["528a962a-4924-4c48-93ce-6ab1f019e52c"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6937-61)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6937-61", "marketing_start_date": "20180801"}], "brand_name": "Paliperidone", "product_id": "0904-6937_23d1a15a-1ba9-46a2-9851-25a00475c0a3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0904-6937", "generic_name": "Paliperidone", "labeler_name": "Major Pharmaceuticals", "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": "20180801", "listing_expiration_date": "20261231"}