{
  "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": "2026-10-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "63304-650",
      "generic_name": "Dextromethorphan Hydrobromide and Quinidine Sulphate",
      "labeler_name": "Sun Pharmaceutical Industries, Inc.",
      "brand_name": "Dextromethorphan Hydrobromide and Quinidine Sulphate",
      "active_ingredients": [
        {
          "name": "DEXTROMETHORPHAN HYDROBROMIDE",
          "strength": "20 mg/1"
        },
        {
          "name": "QUINIDINE SULFATE",
          "strength": "10 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "63304-650-60",
          "description": "60 CAPSULE in 1 BOTTLE (63304-650-60)",
          "marketing_start_date": "20260730",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "rxcui": [
          "1040054"
        ],
        "spl_set_id": [
          "92b54ac4-594e-47b8-a4d3-394a29b425f3"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363304650600"
        ],
        "unii": [
          "9D2RTI9KYH",
          "J13S2394HE"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "CAPSULE",
      "spl_id": "5617af8d-e7b7-1c2c-e063-6294a90a7486",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20260730",
      "product_id": "63304-650_5617af8d-e7b7-1c2c-e063-6294a90a7486",
      "application_number": "ANDA204196",
      "brand_name_base": "Dextromethorphan Hydrobromide and Quinidine Sulphate",
      "pharm_class": [
        "Antiarrhythmic [EPC]",
        "Cytochrome P450 2D6 Inhibitor [EPC]",
        "Cytochrome P450 2D6 Inhibitors [MoA]",
        "Sigma-1 Agonist [EPC]",
        "Sigma-1 Receptor Agonists [MoA]",
        "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]",
        "Uncompetitive NMDA Receptor Antagonists [MoA]"
      ]
    }
  ]
}