{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "70748-387",
      "generic_name": "pitolisant",
      "labeler_name": "Lupin Pharmaceuticals, Inc.",
      "brand_name": "PITOLISANT",
      "active_ingredients": [
        {
          "name": "PITOLISANT HYDROCHLORIDE",
          "strength": "17.8 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "70748-387-01",
          "description": "1 BOTTLE in 1 CARTON (70748-387-01)  / 30 TABLET, FILM COATED in 1 BOTTLE",
          "marketing_start_date": "20261016",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {},
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "e46eef01-594a-49ca-a453-0b680e4ee730",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20261016",
      "product_id": "70748-387_e46eef01-594a-49ca-a453-0b680e4ee730",
      "application_number": "ANDA218846",
      "brand_name_base": "PITOLISANT",
      "pharm_class": [
        "Cytochrome P450 3A4 Inducers [MoA]",
        "Histamine H3 Receptor Antagonists [MoA]",
        "Histamine H3 Receptor Inverse Agonists [MoA]",
        "Histamine-3 Receptor Antagonist/Inverse Agonist [EPC]"
      ]
    }
  ]
}