{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "65219-632",
      "generic_name": "Ropivacaine Hydrochloride",
      "labeler_name": "FRESENIUS KABI USA, LLC",
      "brand_name": "Ropivacaine Hydrochloride",
      "active_ingredients": [
        {
          "name": "ROPIVACAINE HYDROCHLORIDE",
          "strength": "2 mg/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "65219-632-10",
          "description": "24 BAG in 1 CASE (65219-632-10)  / 100 mL in 1 BAG (65219-632-02)",
          "marketing_start_date": "20250203",
          "sample": false
        },
        {
          "package_ndc": "65219-632-20",
          "description": "24 BAG in 1 CASE (65219-632-20)  / 200 mL in 1 BAG (65219-632-04)",
          "marketing_start_date": "20250203",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "FRESENIUS KABI USA, LLC"
        ],
        "rxcui": [
          "1734347",
          "1734355"
        ],
        "spl_set_id": [
          "da4a7675-97bf-4d2a-9fdc-c1b4b2999126"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0365219632047",
          "0365219632023"
        ],
        "unii": [
          "V910P86109"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "INJECTION, SOLUTION",
      "spl_id": "7203f32f-2e48-4924-b882-d4f3863ae952",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "EPIDURAL",
        "INFILTRATION",
        "PERINEURAL"
      ],
      "marketing_start_date": "20241210",
      "product_id": "65219-632_7203f32f-2e48-4924-b882-d4f3863ae952",
      "application_number": "ANDA212808",
      "brand_name_base": "Ropivacaine Hydrochloride",
      "pharm_class": [
        "Amide Local Anesthetic [EPC]",
        "Amides [CS]",
        "Local Anesthesia [PE]"
      ]
    }
  ]
}