INVEGA

{
  "unii": {
    "unii": "838F01T721",
    "rxcui": "679314",
    "inchikey": "PMXMIIMHBWHSKN-UHFFFAOYSA-N",
    "display_name": "PALIPERIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7b8e5b26-b9e4-4704-921b-3c3c0d159916": {
      "match": "brand_token",
      "title": "INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "43",
      "published_date": "2026-03-20"
    }
  },
  "productid": "50458-554_3c5e5b30-a841-4dfe-88ce-361806c9275f",
  "productndc": "50458-554",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021999",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "001",
        "approval_date": "Dec 19, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "002",
        "approval_date": "Dec 19, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "9MG",
        "product_no": "003",
        "approval_date": "Dec 19, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Dec 19, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Aug 26, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALIPERIDONE",
  "proprietary_name": "INVEGA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021999",
  "marketing_category": "NDA",
  "nonproprietary_name": "paliperidone",
  "start_marketing_date": "20090910",
  "active_numerator_strength": "1.5"
}