paliperidone

Generic: paliperidone

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

paliperidone 1.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-803
Product ID 46708-803_be30f3cc-55fb-4a74-9778-60573a7f18c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218330
Listing Expiration 2026-12-31
Marketing Start 2024-09-30

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708803
Hyphenated Format 46708-803

Supplemental Identifiers

RxCUI
672567 672569 672571 866103
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 ANDA218330 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-803-30)
source: ndc

Packages (1)

46708-803-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-803-30)

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": "be30f3cc-55fb-4a74-9778-60573a7f18c6", "openfda": {"nui": ["N0000175430"], "unii": ["838F01T721"], "rxcui": ["672567", "672569", "672571", "866103"], "spl_set_id": ["be30f3cc-55fb-4a74-9778-60573a7f18c6"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-803-30)", "package_ndc": "46708-803-30", "marketing_start_date": "20240930"}], "brand_name": "paliperidone", "product_id": "46708-803_be30f3cc-55fb-4a74-9778-60573a7f18c6", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "46708-803", "generic_name": "paliperidone", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "paliperidone", "active_ingredients": [{"name": "PALIPERIDONE", "strength": "1.5 mg/1"}], "application_number": "ANDA218330", "marketing_category": "ANDA", "marketing_start_date": "20240930", "listing_expiration_date": "20261231"}