{
  "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": "0591-3220",
      "generic_name": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate",
      "labeler_name": "Actavis Pharma, Inc.",
      "dea_schedule": "CIII",
      "brand_name": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate",
      "active_ingredients": [
        {
          "name": "CODEINE PHOSPHATE",
          "strength": "30 mg/1"
        },
        {
          "name": "BUTALBITAL",
          "strength": "50 mg/1"
        },
        {
          "name": "CAFFEINE",
          "strength": "40 mg/1"
        },
        {
          "name": "ACETAMINOPHEN",
          "strength": "325 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0591-3220-01",
          "description": "100 CAPSULE in 1 BOTTLE (0591-3220-01)",
          "marketing_start_date": "20030918",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "rxcui": [
          "993943"
        ],
        "spl_set_id": [
          "a58819b8-a52c-44a7-9ab0-c74480d98506"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175693",
          "M0002177",
          "N0000175739",
          "N0000175729",
          "N0000175790",
          "M0023046"
        ],
        "pharm_class_epc": [
          "Barbiturate [EPC]",
          "Central Nervous System Stimulant [EPC]",
          "Methylxanthine [EPC]"
        ],
        "pharm_class_cs": [
          "Barbiturates [CS]",
          "Xanthines [CS]"
        ],
        "pharm_class_pe": [
          "Central Nervous System Stimulation [PE]"
        ],
        "unii": [
          "GSL05Y1MN6",
          "KHS0AZ4JVK",
          "3G6A5W338E",
          "362O9ITL9D"
        ]
      },
      "marketing_category": "NDA AUTHORIZED GENERIC",
      "dosage_form": "CAPSULE",
      "spl_id": "519e2ce9-e4af-4bd7-96fd-8bee4e3b4537",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20030918",
      "product_id": "0591-3220_519e2ce9-e4af-4bd7-96fd-8bee4e3b4537",
      "application_number": "NDA020232",
      "brand_name_base": "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate",
      "pharm_class": [
        "Barbiturate [EPC]",
        "Barbiturates [CS]",
        "Central Nervous System Stimulant [EPC]",
        "Central Nervous System Stimulation [PE]",
        "Full Opioid Agonists [MoA]",
        "Methylxanthine [EPC]",
        "Opioid Agonist [EPC]",
        "Xanthines [CS]"
      ]
    }
  ]
}