Cardene IV

{
  "unii": {
    "unii": "K5BC5011K3",
    "rxcui": "235230",
    "inchikey": "AIKVCUNQWYTVTO-UHFFFAOYSA-N",
    "display_name": "NICARDIPINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a3e33add-0d09-423a-9109-42e5ba7148d5": {
      "match": "brand_token",
      "title": "CARDENE IV (NICARDIPINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "12",
      "published_date": "2026-04-14"
    }
  },
  "productid": "43066-024_bf4088a4-3cf9-4963-bfdd-79a641a552d7",
  "productndc": "43066-024",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019734",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "25MG/10ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jan 30, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG/200ML (0.1MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 31, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/200ML (0.1MG/ML)",
        "product_no": "003",
        "approval_date": "Jul 31, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "40MG/200ML (0.2MG/ML)",
        "product_no": "004",
        "approval_date": "Nov 7, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG/200ML (0.2MG/ML)",
        "product_no": "005",
        "approval_date": "Nov 7, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NICARDIPINE HYDROCHLORIDE",
  "proprietary_name": "Cardene IV",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019734",
  "marketing_category": "NDA",
  "nonproprietary_name": "nicardipine hydrochloride",
  "start_marketing_date": "19920130",
  "active_numerator_strength": ".2"
}