LAMICTAL

{
  "unii": {
    "unii": "U3H27498KS",
    "rxcui": "28439",
    "inchikey": "PYZRQGJRPPTADH-UHFFFAOYSA-N",
    "display_name": "LAMOTRIGINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d7e3572d-56fe-4727-2bb4-013ccca22678": {
      "match": "brand_token",
      "title": "LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, FOR SUSPENSION LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]",
      "spl_version": "44",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0173-0757_0c7b21d8-3c32-4c65-95cd-cada0421d8e3",
  "productndc": "0173-0757",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022115",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 29, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "May 29, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "May 29, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "May 29, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "005",
        "approval_date": "Apr 14, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "006",
        "approval_date": "Jun 21, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMOTRIGINE",
  "shortage_reason": "Lamotrigine Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "LAMICTAL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022115",
  "marketing_category": "NDA",
  "nonproprietary_name": "lamotrigine",
  "start_marketing_date": "20090706",
  "active_numerator_strength": "200"
}