{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "43386-480",
      "generic_name": "ORPHENADRINE CITRATE",
      "labeler_name": "Lupin Pharmaceuticals, Inc.",
      "brand_name": "ORPHENADRINE CITRATE",
      "active_ingredients": [
        {
          "name": "ORPHENADRINE CITRATE",
          "strength": "100 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "43386-480-24",
          "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24)",
          "marketing_start_date": "19980619",
          "sample": false
        },
        {
          "package_ndc": "43386-480-26",
          "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26)",
          "marketing_start_date": "19980619",
          "sample": false
        },
        {
          "package_ndc": "43386-480-28",
          "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-28)",
          "marketing_start_date": "19980619",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "rxcui": [
          "994521"
        ],
        "spl_set_id": [
          "7b76c8a7-dd0c-481c-8299-26dfd38ce066"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "X0A40N8I4S"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, EXTENDED RELEASE",
      "spl_id": "e80ecc89-bd45-4796-850b-c379a79ac7ab",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "19980619",
      "product_id": "43386-480_e80ecc89-bd45-4796-850b-c379a79ac7ab",
      "application_number": "ANDA040284",
      "brand_name_base": "ORPHENADRINE CITRATE",
      "pharm_class": [
        "Centrally-mediated Muscle Relaxation [PE]",
        "Muscle Relaxant [EPC]"
      ]
    }
  ]
}