fanapt

Generic: iloperidone

Labeler: vanda pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fanapt
Generic Name iloperidone
Labeler vanda pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

iloperidone 8 mg/1

Manufacturer
Vanda Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 43068-902
Product ID 43068-902_55943be8-80ce-4d6a-911a-82eb66b751fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022192
Listing Expiration 2026-12-31
Marketing Start 2018-09-24

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43068902
Hyphenated Format 43068-902

Supplemental Identifiers

RxCUI
848722 848726 848728 848730 848732 848734 848736 848738 848740 848742 848744 848746 848748 848750 848751 848752 2714234 2714235 2720356 2720357
UPC
0343068108029 0343068110022 0343068101020 0343068106025 0343068112026 0343068104021 0343068102027
UNII
VPO7KJ050N
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 fanapt (source: ndc)
Generic Name iloperidone (source: ndc)
Application Number NDA022192 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 BOTTLE (43068-902-14)
source: ndc

Packages (1)

43068-902-14 14 TABLET in 1 BOTTLE (43068-902-14)

Ingredients (1)

iloperidone (8 mg/1)

Linked Drug Pages (1)

FANAPT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "55943be8-80ce-4d6a-911a-82eb66b751fa", "openfda": {"nui": ["N0000175430"], "upc": ["0343068108029", "0343068110022", "0343068101020", "0343068106025", "0343068112026", "0343068104021", "0343068102027"], "unii": ["VPO7KJ050N"], "rxcui": ["848722", "848726", "848728", "848730", "848732", "848734", "848736", "848738", "848740", "848742", "848744", "848746", "848748", "848750", "848751", "848752", "2714234", "2714235", "2720356", "2720357"], "spl_set_id": ["33f60b40-3fca-11de-8f56-0002a5d5c51b"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Vanda Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "14 TABLET in 1 BOTTLE (43068-902-14)", "package_ndc": "43068-902-14", "marketing_start_date": "20180924"}], "brand_name": "FANAPT", "product_id": "43068-902_55943be8-80ce-4d6a-911a-82eb66b751fa", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43068-902", "generic_name": "ILOPERIDONE", "labeler_name": "Vanda Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FANAPT", "active_ingredients": [{"name": "ILOPERIDONE", "strength": "8 mg/1"}], "application_number": "NDA022192", "marketing_category": "NDA", "marketing_start_date": "20180924", "listing_expiration_date": "20261231"}