{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "69168-478",
      "generic_name": "AZELASTINE HYDROCHLORIDE",
      "labeler_name": "Allegiant Health",
      "brand_name": "AZELASTINE HYDROCHLORIDE",
      "active_ingredients": [
        {
          "name": "AZELASTINE HYDROCHLORIDE",
          "strength": "205.5 ug/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "69168-478-02",
          "description": "2 BOTTLE, SPRAY in 1 CARTON (69168-478-02)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY",
          "marketing_start_date": "20250922",
          "sample": false
        },
        {
          "package_ndc": "69168-478-63",
          "description": "1 BOTTLE, SPRAY in 1 CARTON (69168-478-63)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY",
          "marketing_start_date": "20250922",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Allegiant Health"
        ],
        "rxcui": [
          "1797883"
        ],
        "spl_set_id": [
          "3e2fdb0d-c2f5-41ab-b1cd-4fae80648112"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0L591QR10I"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SPRAY, METERED",
      "spl_id": "fc930f5c-a2b9-4e66-814d-ca8d68cc2d29",
      "product_type": "HUMAN OTC DRUG",
      "route": [
        "NASAL"
      ],
      "marketing_start_date": "20250502",
      "product_id": "69168-478_fc930f5c-a2b9-4e66-814d-ca8d68cc2d29",
      "application_number": "ANDA216421",
      "brand_name_base": "AZELASTINE HYDROCHLORIDE",
      "pharm_class": [
        "Histamine H1 Receptor Antagonists [MoA]",
        "Histamine-1 Receptor Antagonist [EPC]"
      ]
    }
  ]
}