Nexterone

{
  "unii": {
    "unii": "976728SY6Z",
    "rxcui": "203114",
    "inchikey": "ITPDYQOUSLNIHG-UHFFFAOYSA-N",
    "display_name": "AMIODARONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e9108958-b8d7-4fba-87c3-9a32990de551": {
      "match": "brand_token",
      "title": "NEXTERONE (AMIODARONE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "23",
      "published_date": "2026-04-09"
    }
  },
  "productid": "43066-360_29c4e07e-f55e-4c19-8638-c4b9eb12efcf",
  "productndc": "43066-360",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022325",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 24, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG/100ML (1.5MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 16, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "360MG/200ML (1.8MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 16, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMIODARONE HYDROCHLORIDE",
  "proprietary_name": "Nexterone",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022325",
  "marketing_category": "NDA",
  "nonproprietary_name": "amiodarone hydrochloride",
  "start_marketing_date": "20101116",
  "active_numerator_strength": "1.8"
}