MITOMYCIN

{
  "unii": {
    "unii": "50SG953SK6",
    "rxcui": "632",
    "inchikey": "NWIBSHFKIJFRCO-WUDYKRTCSA-N",
    "display_name": "MITOMYCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5917f7a7-cd20-407b-8dda-9fd58c5f47a6": {
      "match": "brand_token",
      "title": "MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68001-617_2094e27c-5df6-5cb8-e063-6294a90ae690",
  "productndc": "68001-617",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "216732",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 30, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/VIAL",
        "product_no": "002",
        "approval_date": "Oct 30, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "40MG/VIAL",
        "product_no": "003",
        "approval_date": "Oct 30, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MITOMYCIN",
  "proprietary_name": "MITOMYCIN",
  "active_ingred_unit": "mg/80mL",
  "application_number": "ANDA216732",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MITOMYCIN",
  "start_marketing_date": "20240711",
  "active_numerator_strength": "40"
}