FANAPT

Orange BookUNIISPLATC N05AX14

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

Identification

ManufacturerVanda Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN05AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4306810402
60 TABLET in 1 BOTTLE (43068-104-02)

Annotations

UNII (FDA Substance ID)

VPO7KJ050N

ILOPERIDONE

RxCUI 73178

Orange Book

N022192

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "VPO7KJ050N",
    "rxcui": "73178",
    "inchikey": "XMXHEBAFVSFQEX-UHFFFAOYSA-N",
    "display_name": "ILOPERIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "43068-104_2609a5b3-d7ec-48a9-a32b-54a9b207f9aa",
  "productndc": "43068-104",
  "dosage_form": "TABLET",
  "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": "ILOPERIDONE",
  "proprietary_name": "FANAPT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022192",
  "marketing_category": "NDA",
  "nonproprietary_name": "ILOPERIDONE",
  "start_marketing_date": "20151215",
  "active_numerator_strength": "4"
}

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