{
  "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": "46708-444",
      "generic_name": "Irbesartan and Hydrochlorothiazide",
      "labeler_name": "Alembic Pharmaceuticals Limited",
      "brand_name": "Irbesartan and Hydrochlorothiazide",
      "active_ingredients": [
        {
          "name": "IRBESARTAN",
          "strength": "300 mg/1"
        },
        {
          "name": "HYDROCHLOROTHIAZIDE",
          "strength": "25 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "46708-444-10",
          "description": "10 TABLET in 1 BLISTER PACK (46708-444-10)",
          "marketing_start_date": "20160523",
          "sample": false
        },
        {
          "package_ndc": "46708-444-30",
          "description": "30 TABLET in 1 BOTTLE (46708-444-30)",
          "marketing_start_date": "20160523",
          "sample": false
        },
        {
          "package_ndc": "46708-444-90",
          "description": "90 TABLET in 1 BOTTLE (46708-444-90)",
          "marketing_start_date": "20160523",
          "sample": false
        },
        {
          "package_ndc": "46708-444-91",
          "description": "1000 TABLET in 1 BOTTLE (46708-444-91)",
          "marketing_start_date": "20160523",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Alembic Pharmaceuticals Limited"
        ],
        "rxcui": [
          "310792",
          "310793",
          "485471"
        ],
        "spl_set_id": [
          "9492a1cd-c012-4b43-931d-235220065e1e"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0346708442309",
          "0346708444303",
          "0346708443306"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776",
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]",
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "unii": [
          "0J48LPH2TH",
          "J0E2756Z7N"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET",
      "spl_id": "bbfa2906-f126-40a2-a5c4-8cbe19388fcc",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20160523",
      "product_id": "46708-444_bbfa2906-f126-40a2-a5c4-8cbe19388fcc",
      "application_number": "ANDA091370",
      "brand_name_base": "Irbesartan and Hydrochlorothiazide",
      "pharm_class": [
        "Angiotensin 2 Receptor Antagonists [MoA]",
        "Angiotensin 2 Receptor Blocker [EPC]",
        "Increased Diuresis [PE]",
        "Thiazide Diuretic [EPC]",
        "Thiazides [CS]"
      ]
    }
  ]
}