{
  "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": "68071-3551",
      "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution",
      "labeler_name": "NuCare Pharmaceuticals,Inc.",
      "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution",
      "active_ingredients": [
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "15 mg/5mL"
        },
        {
          "name": "PROMETHAZINE HYDROCHLORIDE",
          "strength": "6.25 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "68071-3551-4",
          "description": "118 mL in 1 BOTTLE (68071-3551-4)",
          "marketing_start_date": "20231201",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "NuCare Pharmaceuticals,Inc."
        ],
        "rxcui": [
          "991528"
        ],
        "spl_set_id": [
          "0b7bfbab-decb-970c-e063-6394a90a50ef"
        ],
        "upc": [
          "0368071355147"
        ],
        "unii": [
          "9D2RTI9KYH",
          "R61ZEH7I1I"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SOLUTION",
      "spl_id": "2d3fb2d4-6352-3f26-e063-6294a90a0163",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20201005",
      "product_id": "68071-3551_2d3fb2d4-6352-3f26-e063-6294a90a0163",
      "application_number": "ANDA040649",
      "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution",
      "pharm_class": [
        "Phenothiazine [EPC]",
        "Phenothiazines [CS]",
        "Sigma-1 Agonist [EPC]",
        "Sigma-1 Receptor Agonists [MoA]",
        "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]",
        "Uncompetitive NMDA Receptor Antagonists [MoA]"
      ]
    }
  ]
}