Clozaril

{
  "unii": {
    "unii": "J60AR2IKIC",
    "rxcui": "2626",
    "inchikey": "QZUDBNBUXVUHMW-UHFFFAOYSA-N",
    "display_name": "CLOZAPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "90876802-0e3a-44c9-9ff7-1754dfbe736a": {
      "match": "brand_token",
      "title": "CLOZARIL (CLOZAPINE) TABLET [HLS THERAPEUTICS (USA), INC.]",
      "spl_version": "21",
      "published_date": "2025-06-30"
    }
  },
  "productid": "69809-0126_14601465-eda2-4063-b606-cb6cfcaaca3d",
  "productndc": "69809-0126",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019758",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Sep 26, 1989"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Sep 26, 1989"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "May 20, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "May 20, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOZAPINE",
  "proprietary_name": "Clozaril",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019758",
  "marketing_category": "NDA",
  "nonproprietary_name": "clozapine",
  "start_marketing_date": "20160506",
  "active_numerator_strength": "25"
}