{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 10
    }
  },
  "results": [
    {
      "update_type": "Revised",
      "initial_posting_date": "11/21/2023",
      "package_ndc": "39822-5550-6",
      "generic_name": "Promethazine Hydrochloride Injection",
      "contact_info": "866-390-4411",
      "availability": "Unvailable",
      "related_info": "Estimated recovery: TBD",
      "openfda": {
        "application_number": [
          "ANDA040737"
        ],
        "brand_name": [
          "PROMETHAZINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "PROMETHAZINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "XGen Pharmaceuticals DJB, Inc."
        ],
        "product_ndc": [
          "39822-5550"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PROMETHAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "992858"
        ],
        "spl_id": [
          "0e860109-725f-1c28-e063-6394a90a50ef"
        ],
        "spl_set_id": [
          "b6f6698f-f23c-452a-9b38-bbb96ab88ae4"
        ],
        "package_ndc": [
          "39822-5550-5",
          "39822-5550-6"
        ],
        "unii": [
          "R61ZEH7I1I"
        ]
      },
      "update_date": "06/23/2026",
      "therapeutic_category": [
        "Analgesia/Addiction",
        "Gastroenterology",
        "Other",
        "Pulmonary/Allergy"
      ],
      "dosage_form": "Injection",
      "presentation": "Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 39822-5550-6)",
      "company_name": "XGen Pharmaceuticals DJB, Inc.",
      "shortage_reason": "Demand increase for the drug",
      "status": "Current"
    }
  ]
}