{
  "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": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "65162-694",
      "generic_name": "Promethazine, Phenylephrine, Codeine",
      "labeler_name": "Amneal Pharmaceuticals LLC",
      "dea_schedule": "CV",
      "brand_name": "Promethazine and Phenylephrine HCl, and Codeine Phosphate",
      "active_ingredients": [
        {
          "name": "PROMETHAZINE HYDROCHLORIDE",
          "strength": "6.25 mg/5mL"
        },
        {
          "name": "PHENYLEPHRINE HYDROCHLORIDE",
          "strength": "5 mg/5mL"
        },
        {
          "name": "CODEINE PHOSPHATE",
          "strength": "10 mg/5mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "65162-694-86",
          "description": "118 mL in 1 BOTTLE (65162-694-86)",
          "marketing_start_date": "20131101",
          "sample": false
        },
        {
          "package_ndc": "65162-694-90",
          "description": "473 mL in 1 BOTTLE (65162-694-90)",
          "marketing_start_date": "20131101",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC"
        ],
        "rxcui": [
          "996757"
        ],
        "spl_set_id": [
          "5f23b254-872b-4e88-91be-710c3ea7687b"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "R61ZEH7I1I",
          "04JA59TNSJ",
          "GSL05Y1MN6"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SYRUP",
      "spl_id": "fa597180-cb04-48de-ba6c-1cc3781d7f31",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20131101",
      "product_id": "65162-694_fa597180-cb04-48de-ba6c-1cc3781d7f31",
      "application_number": "ANDA200963",
      "brand_name_base": "Promethazine and Phenylephrine HCl, and Codeine Phosphate",
      "pharm_class": [
        "Adrenergic alpha1-Agonists [MoA]",
        "Full Opioid Agonists [MoA]",
        "Opioid Agonist [EPC]",
        "Phenothiazine [EPC]",
        "Phenothiazines [CS]",
        "alpha-1 Adrenergic Agonist [EPC]"
      ]
    }
  ]
}