{
  "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": "0116-4026",
      "generic_name": "NYSTATIN",
      "labeler_name": "Xttrium Laboratories, Inc.",
      "brand_name": "Nystatin Oral Suspension",
      "active_ingredients": [
        {
          "name": "NYSTATIN",
          "strength": "100000 [USP'U]/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "0116-4026-11",
          "description": "10 TRAY in 1 CASE (0116-4026-11)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05)",
          "marketing_start_date": "20260206",
          "sample": false
        },
        {
          "package_ndc": "0116-4026-16",
          "description": "473 mL in 1 BOTTLE, PLASTIC (0116-4026-16)",
          "marketing_start_date": "20260209",
          "sample": false
        },
        {
          "package_ndc": "0116-4026-50",
          "description": "5 TRAY in 1 CASE (0116-4026-50)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4026-05)",
          "marketing_start_date": "20260209",
          "sample": false
        }
      ],
      "listing_expiration_date": "20271231",
      "openfda": {
        "manufacturer_name": [
          "Xttrium Laboratories, Inc."
        ],
        "rxcui": [
          "312055"
        ],
        "spl_set_id": [
          "4a670371-d373-1ba6-e063-6394a90a13b6"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175498",
          "M0017172"
        ],
        "pharm_class_epc": [
          "Polyene Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Polyenes [CS]"
        ],
        "unii": [
          "BDF1O1C72E"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SUSPENSION",
      "spl_id": "4a2ff89a-52fe-8bf9-e063-6394a90a7f1d",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20260206",
      "product_id": "0116-4026_4a2ff89a-52fe-8bf9-e063-6394a90a7f1d",
      "application_number": "ANDA062512",
      "brand_name_base": "Nystatin Oral Suspension",
      "pharm_class": [
        "Polyene Antifungal [EPC]",
        "Polyenes [CS]"
      ]
    }
  ]
}