Sirolimus

{
  "unii": {
    "unii": "W36ZG6FT64",
    "rxcui": "35302",
    "inchikey": "QFJCIRLUMZQUOT-HPLJOQBZSA-N",
    "display_name": "SIROLIMUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ad39eb60-1fa0-4722-8ba1-523194921c2a": {
      "match": "brand_token",
      "title": "SIROLIMUS TABLET, FILM COATED [NORTHSTAR RX LLC]",
      "spl_version": "4",
      "published_date": "2026-05-13"
    }
  },
  "productid": "59762-1001_8f2761f9-9bc3-47c3-8093-6375a39d1034",
  "productndc": "59762-1001",
  "dosage_form": "TABLET, SUGAR COATED",
  "orange_book": {
    "appl_no": "021110",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 25, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 22, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Feb 23, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "004",
        "approval_date": "Jan 25, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIROLIMUS",
  "proprietary_name": "Sirolimus",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021110",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "SIROLIMUS",
  "start_marketing_date": "20140107",
  "active_numerator_strength": ".5"
}