PREZISTA

{
  "unii": {
    "unii": "33O78XF0BW",
    "rxcui": "644682",
    "inchikey": "QWSHKNICRJHQCY-VBTXLZOXSA-N",
    "display_name": "DARUNAVIR ETHANOLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "814301f9-c990-46a5-b481-2879a521a16f": {
      "match": "brand_token",
      "title": "PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP]",
      "spl_version": "58",
      "published_date": "2025-09-01"
    }
  },
  "productid": "59676-563_3d80bc62-24ac-c092-e063-6394a90a7bba",
  "productndc": "59676-563",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021976",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 23, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Feb 25, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Oct 21, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Dec 18, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Dec 18, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "006",
        "approval_date": "Nov 9, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DARUNAVIR ETHANOLATE",
  "proprietary_name": "PREZISTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021976",
  "marketing_category": "NDA",
  "nonproprietary_name": "darunavir",
  "start_marketing_date": "20090114",
  "active_numerator_strength": "75"
}