{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "70404-077",
      "generic_name": "Prednisolone oral",
      "labeler_name": "Tulex Pharmaceuticals Inc",
      "brand_name": "Prednisolone",
      "active_ingredients": [
        {
          "name": "PREDNISOLONE",
          "strength": "15 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "70404-077-14",
          "description": "240 mL in 1 BOTTLE (70404-077-14)",
          "marketing_start_date": "20260708",
          "sample": false
        },
        {
          "package_ndc": "70404-077-16",
          "description": "480 mL in 1 BOTTLE (70404-077-16)",
          "marketing_start_date": "20260708",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Tulex Pharmaceuticals Inc"
        ],
        "rxcui": [
          "283077"
        ],
        "spl_set_id": [
          "757b41c4-a0fe-4a09-8816-a4cdb7558f41"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0352817860163",
          "0352817860088"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "9PHQ9Y1OLM"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SOLUTION",
      "spl_id": "561d8c9c-b67f-7fb2-e063-6394a90a0316",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20260708",
      "product_id": "70404-077_561d8c9c-b67f-7fb2-e063-6394a90a0316",
      "application_number": "ANDA219509",
      "brand_name_base": "Prednisolone",
      "pharm_class": [
        "Corticosteroid Hormone Receptor Agonists [MoA]",
        "Corticosteroid [EPC]"
      ]
    }
  ]
}