FANAPT

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerVanda Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4306811403
1 BLISTER PACK in 1 DOSE PACK (43068-114-03) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N022192

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "33f60b40-3fca-11de-8f56-0002a5d5c51b": {
      "match": "brand_token",
      "title": "FANAPT (ILOPERIDONE) TABLET FANAPT (ILOPERIDONE) KIT [VANDA PHARMACEUTICALS INC.]",
      "spl_version": "35",
      "published_date": "2026-05-13"
    }
  },
  "productid": "43068-114_2609a5b3-d7ec-48a9-a32b-54a9b207f9aa",
  "productndc": "43068-114",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022192",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "May 6, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "May 6, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4MG",
        "product_no": "003",
        "approval_date": "May 6, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6MG",
        "product_no": "004",
        "approval_date": "May 6, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "8MG",
        "product_no": "005",
        "approval_date": "May 6, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "006",
        "approval_date": "May 6, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12MG",
        "product_no": "007",
        "approval_date": "May 6, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "FANAPT",
  "active_ingred_unit": null,
  "application_number": "NDA022192",
  "marketing_category": "NDA",
  "nonproprietary_name": "ILOPERIDONE",
  "start_marketing_date": "20250501",
  "active_numerator_strength": null
}

Access this data programmatically

Query FANAPT and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs