DAPZURA RT

{
  "unii": {
    "unii": "NWQ5N31VKK",
    "rxcui": "22299",
    "inchikey": "DOAKLVKFURWEDJ-QCMAZARJSA-N",
    "display_name": "DAPTOMYCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "cb1283e1-35b8-425c-b338-d9ac0c7161f8": {
      "match": "brand_token",
      "title": "DAPZURA RT (DAPTOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "7",
      "published_date": "2026-05-21"
    }
  },
  "productid": "60977-145_b5b302e0-d9e2-4032-ae95-cad85b08e130",
  "productndc": "60977-145",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "213645",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jan 25, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "350MG/50ML (7MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 27, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG/50ML (10MG/ML)",
        "product_no": "003",
        "approval_date": "Feb 27, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "700MG/100ML (7MG/ML)",
        "product_no": "004",
        "approval_date": "Feb 27, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "005",
        "approval_date": "Feb 27, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DAPTOMYCIN",
  "proprietary_name": "DAPZURA RT",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA213645",
  "marketing_category": "NDA",
  "nonproprietary_name": "daptomycin",
  "start_marketing_date": "20220125",
  "active_numerator_strength": "500"
}