{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20260811",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20211203",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20230526",
          "review_priority": "UNKNOWN",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "ANDA213320",
      "sponsor_name": "HARMAN FINOCHEM",
      "openfda": {
        "application_number": [
          "ANDA213320"
        ],
        "brand_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
          "Ascend Laboratories, LLC"
        ],
        "product_ndc": [
          "23155-841",
          "23155-842",
          "23155-843",
          "67877-930",
          "67877-931",
          "67877-932"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "861004",
          "861007",
          "861010"
        ],
        "spl_id": [
          "5de825b4-d3e9-474d-9f17-ceed2d4ea87c",
          "8c7835fa-3f68-4850-b1da-34893bafb485"
        ],
        "spl_set_id": [
          "b63bfafa-db4c-4fb8-84cd-ff73a5e7d320",
          "8c7835fa-3f68-4850-b1da-34893bafb485"
        ],
        "package_ndc": [
          "23155-841-01",
          "23155-841-05",
          "23155-841-10",
          "23155-842-01",
          "23155-842-05",
          "23155-842-10",
          "23155-843-01",
          "23155-843-05",
          "23155-843-10",
          "67877-930-01",
          "67877-930-05",
          "67877-930-10",
          "67877-931-01",
          "67877-931-05",
          "67877-931-10",
          "67877-932-01",
          "67877-932-05",
          "67877-932-10"
        ],
        "unii": [
          "786Z46389E"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "METFORMIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "METFORMIN HYDROCHLORIDE",
              "strength": "850MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "METFORMIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "METFORMIN HYDROCHLORIDE",
              "strength": "1GM"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "METFORMIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "METFORMIN HYDROCHLORIDE",
              "strength": "500MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}