{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "71288-037",
      "generic_name": "lefamulin acetate",
      "labeler_name": "Meitheal Pharmaceuticals Inc.",
      "brand_name": "Xenleta",
      "active_ingredients": [
        {
          "name": "LEFAMULIN ACETATE",
          "strength": "600 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "71288-037-10",
          "description": "10 TABLET, COATED in 1 BLISTER PACK (71288-037-10)",
          "marketing_start_date": "20190909",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Meitheal Pharmaceuticals Inc."
        ],
        "rxcui": [
          "2198948",
          "2198953",
          "2198961",
          "2198966",
          "2747671",
          "2747672"
        ],
        "spl_set_id": [
          "eb972ea8-7502-422e-84bb-66cb8e93ca06"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175833",
          "N0000175835",
          "N0000175980",
          "N0000008556",
          "N0000175089"
        ],
        "pharm_class_moa": [
          "Acidifying Activity [MoA]",
          "Calcium Chelating Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Calculi Dissolution Agent [EPC]",
          "Anti-coagulant [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Coagulation Factor Activity [PE]"
        ],
        "unii": [
          "HDN0B924X4",
          "XF417D3PSL"
        ]
      },
      "marketing_category": "NDA",
      "dosage_form": "TABLET, COATED",
      "spl_id": "b9951406-492b-4420-89cc-24fd655824b3",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20190909",
      "product_id": "71288-037_b9951406-492b-4420-89cc-24fd655824b3",
      "application_number": "NDA211672",
      "brand_name_base": "Xenleta",
      "pharm_class": [
        "Cytochrome P450 3A Inhibitors [MoA]",
        "Cytochrome P450 3A4 Inhibitors [MoA]",
        "Diterpenes [CS]",
        "Pleuromutilin Antibacterial [EPC]"
      ]
    }
  ]
}