{
  "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": "70518-4309",
      "generic_name": "Butalbital, Acetaminophen, and Caffeine",
      "labeler_name": "REMEDYREPACK INC.",
      "dea_schedule": "CIII",
      "brand_name": "Butalbital, Acetaminophen, Caffeine",
      "active_ingredients": [
        {
          "name": "BUTALBITAL",
          "strength": "50 mg/1"
        },
        {
          "name": "ACETAMINOPHEN",
          "strength": "325 mg/1"
        },
        {
          "name": "CAFFEINE",
          "strength": "40 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "70518-4309-0",
          "description": "100 TABLET in 1 BOTTLE, PLASTIC (70518-4309-0)",
          "marketing_start_date": "20250314",
          "sample": false
        },
        {
          "package_ndc": "70518-4309-1",
          "description": "60 TABLET in 1 BOTTLE, PLASTIC (70518-4309-1)",
          "marketing_start_date": "20250804",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "REMEDYREPACK INC."
        ],
        "rxcui": [
          "238154"
        ],
        "spl_set_id": [
          "dc2bb7fc-1722-4865-a02c-be5e5c211505"
        ],
        "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": [
          "KHS0AZ4JVK",
          "362O9ITL9D",
          "3G6A5W338E"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET",
      "spl_id": "5a99bd98-6741-2a2f-e063-6394a90a0229",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20250314",
      "product_id": "70518-4309_5a99bd98-6741-2a2f-e063-6394a90a0229",
      "application_number": "ANDA209587",
      "brand_name_base": "Butalbital, Acetaminophen, Caffeine",
      "pharm_class": [
        "Barbiturate [EPC]",
        "Barbiturates [CS]",
        "Central Nervous System Stimulant [EPC]",
        "Central Nervous System Stimulation [PE]",
        "Methylxanthine [EPC]",
        "Xanthines [CS]"
      ]
    }
  ]
}