{
  "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": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20201030",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20181217",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA210839",
      "sponsor_name": "AMNEAL",
      "openfda": {
        "application_number": [
          "ANDA210839"
        ],
        "brand_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "generic_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "70121-1576"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NOREPINEPHRINE BITARTRATE"
        ],
        "rxcui": [
          "242969"
        ],
        "spl_id": [
          "0d4141ef-d701-496b-a84a-a4c49b3d0767"
        ],
        "spl_set_id": [
          "256264b1-ddf6-42b7-8a09-194fffea65e2"
        ],
        "package_ndc": [
          "70121-1576-1",
          "70121-1576-7"
        ],
        "unii": [
          "IFY5PE3ZRW"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "NOREPINEPHRINE BITARTRATE",
          "active_ingredients": [
            {
              "name": "NOREPINEPHRINE BITARTRATE",
              "strength": "EQ 1MG BASE/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}