{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "0121-1854",
      "generic_name": "Promethazine Hydrochloride",
      "labeler_name": "PAI Holdings, LLC dba PAI Pharma",
      "brand_name": "Promethazine Hydrochloride",
      "active_ingredients": [
        {
          "name": "PROMETHAZINE HYDROCHLORIDE",
          "strength": "6.25 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0121-1854-16",
          "description": "473 mL in 1 BOTTLE (0121-1854-16)",
          "marketing_start_date": "20250807",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "PAI Holdings, LLC dba PAI Pharma"
        ],
        "rxcui": [
          "992432"
        ],
        "spl_set_id": [
          "7a186bcd-ab8c-4695-8289-4cd33bb551cf"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R61ZEH7I1I"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SOLUTION",
      "spl_id": "628c0c05-9610-4a8e-ae9b-f6aad47993d6",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20250807",
      "product_id": "0121-1854_628c0c05-9610-4a8e-ae9b-f6aad47993d6",
      "application_number": "ANDA040643",
      "brand_name_base": "Promethazine Hydrochloride",
      "pharm_class": [
        "Phenothiazine [EPC]",
        "Phenothiazines [CS]"
      ]
    }
  ]
}