{
  "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": "46708-634",
      "generic_name": "Dabigatran Etexilate",
      "labeler_name": "Alembic Pharmaceuticals Limited",
      "brand_name": "Dabigatran Etexilate",
      "active_ingredients": [
        {
          "name": "DABIGATRAN ETEXILATE MESYLATE",
          "strength": "75 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "46708-634-06",
          "description": "10 BLISTER PACK in 1 CARTON (46708-634-06)  / 6 CAPSULE in 1 BLISTER PACK",
          "marketing_start_date": "20240614",
          "sample": false
        },
        {
          "package_ndc": "46708-634-60",
          "description": "60 CAPSULE in 1 BOTTLE (46708-634-60)",
          "marketing_start_date": "20240614",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Alembic Pharmaceuticals Limited"
        ],
        "rxcui": [
          "1037045",
          "1037179",
          "1723476"
        ],
        "spl_set_id": [
          "13649035-a498-4e31-a7ea-8b18cedceca7"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0346708634605",
          "0346708636609"
        ],
        "unii": [
          "SC7NUW5IIT"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "CAPSULE",
      "spl_id": "4f8d4596-bc1a-48a1-8f6a-caf816a2037f",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20240614",
      "product_id": "46708-634_4f8d4596-bc1a-48a1-8f6a-caf816a2037f",
      "application_number": "ANDA215233",
      "brand_name_base": "Dabigatran Etexilate",
      "pharm_class": [
        "Direct Thrombin Inhibitor [EPC]",
        "Thrombin Inhibitors [MoA]"
      ]
    }
  ]
}