Focalin

{
  "unii": {
    "unii": "1678OK0E08",
    "rxcui": "353105",
    "inchikey": "JUMYIBMBTDDLNG-OJERSXHUSA-N",
    "display_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2016f5c2-95d2-4655-af65-c588c2bf5e6d": {
      "match": "brand_token",
      "title": "FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE) TABLET [SANDOZ INC]",
      "spl_version": "2",
      "published_date": "2025-12-12"
    }
  },
  "productid": "0078-0608_fd5dd3b3-6bdf-437e-a763-1a07f9631121",
  "productndc": "0078-0608",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021802",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 26, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "May 26, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "May 26, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Aug 1, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "005",
        "approval_date": "Oct 23, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "006",
        "approval_date": "Aug 11, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "35MG",
        "product_no": "007",
        "approval_date": "Apr 21, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "008",
        "approval_date": "Apr 21, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
  "proprietary_name": "Focalin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021802",
  "marketing_category": "NDA",
  "nonproprietary_name": "dexmethylphenidate hydrochloride",
  "start_marketing_date": "20050531",
  "active_numerator_strength": "25"
}