{
  "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": "33342-376",
      "generic_name": "Hydralazine Hydrochloride",
      "labeler_name": "Macleods Pharmaceuticals Limited",
      "brand_name": "Hydralazine Hydrochloride",
      "active_ingredients": [
        {
          "name": "HYDRALAZINE HYDROCHLORIDE",
          "strength": "50 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "33342-376-11",
          "description": "100 TABLET in 1 BOTTLE (33342-376-11)",
          "marketing_start_date": "20240826",
          "sample": false
        },
        {
          "package_ndc": "33342-376-12",
          "description": "10 BLISTER PACK in 1 CARTON (33342-376-12)  / 10 TABLET in 1 BLISTER PACK",
          "marketing_start_date": "20240826",
          "sample": false
        },
        {
          "package_ndc": "33342-376-44",
          "description": "1000 TABLET in 1 BOTTLE (33342-376-44)",
          "marketing_start_date": "20240826",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "rxcui": [
          "905199",
          "905222",
          "905225",
          "905395"
        ],
        "spl_set_id": [
          "f9f56326-6d72-47d3-89ac-3625b8a6d713"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0333342377111",
          "0333342375445",
          "0333342374110",
          "0333342376114",
          "0333342374448",
          "0333342376442",
          "0333342377449",
          "0333342375117"
        ],
        "unii": [
          "FD171B778Y"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET",
      "spl_id": "f9f56326-6d72-47d3-89ac-3625b8a6d713",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20240826",
      "product_id": "33342-376_f9f56326-6d72-47d3-89ac-3625b8a6d713",
      "application_number": "ANDA211010",
      "brand_name_base": "Hydralazine Hydrochloride",
      "pharm_class": [
        "Arteriolar Vasodilation [PE]",
        "Arteriolar Vasodilator [EPC]"
      ]
    }
  ]
}