{
  "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": "2026-10-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "68083-138",
      "generic_name": "Haloperidol Decanoate",
      "labeler_name": "Gland Pharma Limited",
      "brand_name": "Haloperidol Decanoate",
      "active_ingredients": [
        {
          "name": "HALOPERIDOL DECANOATE",
          "strength": "100 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68083-138-02",
          "description": "1 VIAL in 1 CARTON (68083-138-02)  / 5 mL in 1 VIAL",
          "marketing_start_date": "20170116",
          "sample": false
        },
        {
          "package_ndc": "68083-138-10",
          "description": "10 VIAL in 1 CARTON (68083-138-10)  / 1 mL in 1 VIAL",
          "marketing_start_date": "20170116",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Gland Pharma Limited"
        ],
        "rxcui": [
          "859867",
          "859871",
          "1719803",
          "1719862"
        ],
        "spl_set_id": [
          "1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368083137106",
          "0368083138103"
        ],
        "unii": [
          "AC20PJ4101"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "INJECTION",
      "spl_id": "09213604-f576-4578-ad34-92b448e3c782",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "INTRAMUSCULAR"
      ],
      "marketing_start_date": "20170116",
      "product_id": "68083-138_09213604-f576-4578-ad34-92b448e3c782",
      "application_number": "ANDA205241",
      "brand_name_base": "Haloperidol Decanoate",
      "pharm_class": [
        "Typical Antipsychotic [EPC]"
      ]
    }
  ]
}