{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20030129"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20200702",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20050505",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA040489",
      "sponsor_name": "OXFORD PHARMS",
      "openfda": {
        "application_number": [
          "ANDA040489"
        ],
        "brand_name": [
          "METHOCARBAMOL"
        ],
        "generic_name": [
          "METHOCARBAMOL"
        ],
        "manufacturer_name": [
          "GENTEX PHARMA, LLC",
          "Key Therapeutics",
          "Oxford Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "15014-910",
          "70868-901",
          "69584-611",
          "69584-612",
          "70868-910"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METHOCARBAMOL"
        ],
        "rxcui": [
          "197943",
          "197944"
        ],
        "spl_id": [
          "35c044a6-90c1-55f8-e063-6294a90aad48",
          "241421f2-c6b7-78cc-e063-6394a90ae650",
          "869612eb-80c5-498d-b4c1-a4f26e93a542",
          "24143189-700c-75f8-e063-6394a90ac5ce"
        ],
        "spl_set_id": [
          "35c044a6-90c0-55f8-e063-6294a90aad48",
          "a88a6c84-b55a-4b6b-ac01-554079f6e304",
          "06dc72a6-ef3a-425a-9194-a9d228093cc4",
          "cf931001-95bd-4900-98d5-f5ef54b49d99"
        ],
        "package_ndc": [
          "15014-910-10",
          "70868-901-90",
          "69584-611-09",
          "69584-611-10",
          "69584-611-50",
          "69584-611-90",
          "69584-611-01",
          "69584-612-09",
          "69584-612-10",
          "69584-612-50",
          "69584-612-90",
          "69584-612-01",
          "70868-910-10"
        ],
        "nui": [
          "N0000175730",
          "N0000175737"
        ],
        "pharm_class_pe": [
          "Centrally-mediated Muscle Relaxation [PE]"
        ],
        "pharm_class_epc": [
          "Muscle Relaxant [EPC]"
        ],
        "unii": [
          "125OD7737X"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "METHOCARBAMOL",
          "active_ingredients": [
            {
              "name": "METHOCARBAMOL",
              "strength": "750MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "METHOCARBAMOL",
          "active_ingredients": [
            {
              "name": "METHOCARBAMOL",
              "strength": "500MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        }
      ]
    }
  ]
}