{
  "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": "53746-831",
      "generic_name": "Ciprofloxacin and Dexamethasone",
      "labeler_name": "Amneal Pharmaceuticals of New York LLC",
      "brand_name": "Ciprofloxacin and Dexamethasone",
      "active_ingredients": [
        {
          "name": "CIPROFLOXACIN HYDROCHLORIDE",
          "strength": "3 mg/mL"
        },
        {
          "name": "DEXAMETHASONE",
          "strength": "1 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "53746-831-53",
          "description": "1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53)  / 7.5 mL in 1 BOTTLE, PLASTIC",
          "marketing_start_date": "20240326",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Amneal Pharmaceuticals of New York LLC"
        ],
        "rxcui": [
          "403908"
        ],
        "spl_set_id": [
          "55426495-5fd1-44ca-afcc-ffbbb0a0a569"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "4BA73M5E37",
          "7S5I7G3JQL"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SUSPENSION/ DROPS",
      "spl_id": "718cd533-d887-4ef1-a7d0-fca696242bb2",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "AURICULAR (OTIC)"
      ],
      "marketing_start_date": "20240326",
      "product_id": "53746-831_718cd533-d887-4ef1-a7d0-fca696242bb2",
      "application_number": "ANDA216501",
      "brand_name_base": "Ciprofloxacin and Dexamethasone",
      "pharm_class": [
        "Corticosteroid Hormone Receptor Agonists [MoA]",
        "Corticosteroid [EPC]",
        "Cytochrome P450 1A2 Inhibitors [MoA]",
        "Fluoroquinolone Antibacterial [EPC]",
        "Fluoroquinolones [CS]"
      ]
    }
  ]
}