RISPERDAL M-TAB

{
  "unii": {
    "unii": "L6UH7ZF8HC",
    "rxcui": "35636",
    "inchikey": "RAPZEAPATHNIPO-UHFFFAOYSA-N",
    "display_name": "RISPERIDONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bb34ee82-d2c2-43b8-ba21-2825c0954691": {
      "match": "brand_token",
      "title": "RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "38",
      "published_date": "2025-11-17"
    }
  },
  "productid": "50458-395_408e48a3-35fc-49e1-8e01-44305d9083a4",
  "productndc": "50458-395",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "021444",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Apr 2, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Apr 2, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Apr 2, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Dec 23, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Dec 23, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISPERIDONE",
  "proprietary_name": "RISPERDAL M-TAB",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021444",
  "marketing_category": "NDA",
  "nonproprietary_name": "risperidone",
  "start_marketing_date": "20030402",
  "active_numerator_strength": ".5"
}