Efudex

{
  "unii": {
    "unii": "U3P01618RT",
    "rxcui": "4492",
    "inchikey": "GHASVSINZRGABV-UHFFFAOYSA-N",
    "display_name": "FLUOROURACIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "35de1c1c-bef5-46c5-b6f8-ea032147411c": {
      "match": "brand_token",
      "title": "EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [BAUSCH HEALTH US, LLC]",
      "spl_version": "20",
      "published_date": "2025-04-25"
    }
  },
  "productid": "0187-3204_3375c5f7-9b6f-8ca1-e063-6394a90aaff8",
  "productndc": "0187-3204",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "016831",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "5%",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROURACIL",
  "proprietary_name": "Efudex",
  "active_ingred_unit": "g/40g",
  "application_number": "NDA016831",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fluorouracil",
  "start_marketing_date": "19700729",
  "active_numerator_strength": "2"
}