Topamax

{
  "unii": {
    "unii": "0H73WJJ391",
    "rxcui": "38404",
    "inchikey": "KJADKKWYZYXHBB-XBWDGYHZSA-N",
    "display_name": "TOPIRAMATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "21628112-0c47-11df-95b3-498d55d89593": {
      "match": "brand_token",
      "title": "TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "30",
      "published_date": "2026-03-16"
    }
  },
  "productid": "50458-645_1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8",
  "productndc": "50458-645",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "020844",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Oct 26, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Oct 26, 1998"
      },
      {
        "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        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "Oct 26, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOPIRAMATE",
  "proprietary_name": "Topamax",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020844",
  "marketing_category": "NDA",
  "nonproprietary_name": "topiramate",
  "start_marketing_date": "19981101",
  "active_numerator_strength": "25"
}