{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "13107-103",
      "generic_name": "Oxymorphone Hydrochloride",
      "labeler_name": "Aurolife Pharma, LLC",
      "dea_schedule": "CII",
      "brand_name": "Oxymorphone Hydrochloride",
      "active_ingredients": [
        {
          "name": "OXYMORPHONE HYDROCHLORIDE",
          "strength": "5 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "13107-103-01",
          "description": "100 TABLET in 1 BOTTLE (13107-103-01)",
          "marketing_start_date": "20160426",
          "sample": false
        },
        {
          "package_ndc": "13107-103-30",
          "description": "30 TABLET in 1 BOTTLE (13107-103-30)",
          "marketing_start_date": "20160426",
          "sample": false
        },
        {
          "package_ndc": "13107-103-99",
          "description": "1000 TABLET in 1 BOTTLE (13107-103-99)",
          "marketing_start_date": "20160426",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Aurolife Pharma, LLC"
        ],
        "rxcui": [
          "977939",
          "977942"
        ],
        "spl_set_id": [
          "22c7652a-aa16-4fa8-89d9-517e69059068"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5Y2EI94NBC"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET",
      "spl_id": "cca2aea2-3582-4917-9996-d6834de71db6",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20160426",
      "product_id": "13107-103_cca2aea2-3582-4917-9996-d6834de71db6",
      "application_number": "ANDA204459",
      "brand_name_base": "Oxymorphone Hydrochloride",
      "pharm_class": [
        "Full Opioid Agonists [MoA]",
        "Opioid Agonist [EPC]"
      ]
    }
  ]
}