{
  "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": 7
    }
  },
  "results": [
    {
      "update_type": "Reverified",
      "initial_posting_date": "10/12/2022",
      "package_ndc": "70010-113-01",
      "generic_name": "Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet",
      "contact_info": "877-770-3183",
      "availability": "Unavailable",
      "related_info": "Estimated recovery: October 2026",
      "openfda": {
        "application_number": [
          "ANDA215771"
        ],
        "brand_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"
        ],
        "generic_name": [
          "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"
        ],
        "manufacturer_name": [
          "Granules Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "70010-113",
          "70010-111",
          "70010-112",
          "70010-114",
          "70010-115",
          "70010-116",
          "70010-117"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DEXTROAMPHETAMINE SACCHARATE",
          "AMPHETAMINE ASPARTATE MONOHYDRATE",
          "DEXTROAMPHETAMINE SULFATE",
          "AMPHETAMINE SULFATE"
        ],
        "rxcui": [
          "541363",
          "541878",
          "541892",
          "577957",
          "577961",
          "687043",
          "1009145"
        ],
        "spl_id": [
          "56c7c921-e560-c5ad-e063-6294a90a4c81"
        ],
        "spl_set_id": [
          "b0b4eccc-34c7-483d-966f-82d588358e1b"
        ],
        "package_ndc": [
          "70010-111-01",
          "70010-111-03",
          "70010-112-01",
          "70010-112-03",
          "70010-113-01",
          "70010-113-03",
          "70010-114-01",
          "70010-114-03",
          "70010-115-01",
          "70010-115-03",
          "70010-116-01",
          "70010-116-03",
          "70010-117-01",
          "70010-117-03"
        ],
        "unii": [
          "O1ZPV620O4",
          "G83415V073",
          "6DPV8NK46S",
          "JJ768O327N"
        ]
      },
      "update_date": "09/18/2026",
      "therapeutic_category": [
        "Psychiatry"
      ],
      "dosage_form": "Tablet",
      "presentation": "Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 70010-113-01)",
      "company_name": "Granules Pharmaceuticals Inc.",
      "shortage_reason": "Shortage of an active ingredient",
      "status": "Current"
    }
  ]
}