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
4306890608
1 BLISTER PACK in 1 DOSE PACK (43068-906-08) / 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": "43068-906_2609a5b3-d7ec-48a9-a32b-54a9b207f9aa",
  "productndc": "43068-906",
  "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
}

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