{
  "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": "2026-10-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "17856-4024",
      "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide",
      "labeler_name": "Atlantic Biologicals Corp.",
      "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide",
      "active_ingredients": [
        {
          "name": "PROMETHAZINE HYDROCHLORIDE",
          "strength": "6.25 mg/5mL"
        },
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "15 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "17856-4024-1",
          "description": "72 CUP, UNIT-DOSE in 1 CASE (17856-4024-1)  / 5 mL in 1 CUP, UNIT-DOSE",
          "marketing_start_date": "20260424",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Atlantic Biologicals Corp."
        ],
        "rxcui": [
          "991528"
        ],
        "spl_set_id": [
          "5022379d-05ef-63f2-e063-6294a90a2189"
        ],
        "unii": [
          "R61ZEH7I1I",
          "9D2RTI9KYH"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SYRUP",
      "spl_id": "50223b67-c0bd-f577-e063-6394a90a8d8f",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20250407",
      "product_id": "17856-4024_50223b67-c0bd-f577-e063-6394a90a8d8f",
      "application_number": "ANDA088864",
      "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide",
      "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]"
      ]
    }
  ]
}