Nystatin

{
  "unii": {
    "unii": "BDF1O1C72E",
    "rxcui": "7597",
    "inchikey": null,
    "display_name": "NYSTATIN",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "50737729-a4a4-e747-e063-6394a90adcc5": {
      "match": "brand_token",
      "title": "NYSTATIN SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "62135-813_4c47b825-6b93-307f-e063-6394a90a2b7d",
  "productndc": "62135-813",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "050299",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NYSTATIN",
  "proprietary_name": "Nystatin",
  "active_ingred_unit": "U/mL",
  "application_number": "NDA050299",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Nystatin",
  "start_marketing_date": "19710414",
  "active_numerator_strength": "100000"
}