PREZCOBIX PED

{
  "unii": {
    "unii": "LW2E03M5PG",
    "rxcui": "1306284",
    "inchikey": "ZCIGNRJZKPOIKD-CQXVEOKZSA-N",
    "display_name": "COBICISTAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f": {
      "match": "brand_token",
      "title": "PREZCOBIX (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FILM COATED PREZCOBIX PED (DARUNAVIR ETHANOLATE AND COBICISTAT) TABLET, FOR SUSPENSION [JANSSEN PRODUCTS, LP]",
      "spl_version": "28",
      "published_date": "2026-03-18"
    }
  },
  "productid": "59676-577_9d92f536-2a35-4d1d-baca-8d87e8b8dcaf",
  "productndc": "59676-577",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "205395",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;EQ 800MG BASE",
        "product_no": "001",
        "approval_date": "Jan 29, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;EQ 675MG BASE",
        "product_no": "002",
        "approval_date": "Mar 21, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COBICISTAT; DARUNAVIR ETHANOLATE",
  "proprietary_name": "PREZCOBIX PED",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205395",
  "marketing_category": "NDA",
  "nonproprietary_name": "DARUNAVIR ETHANOLATE and COBICISTAT",
  "start_marketing_date": "20260227",
  "active_numerator_strength": "90; 600"
}