SCEMBLIX

{
  "unii": {
    "unii": "C5U34S9XFV",
    "rxcui": "2584303",
    "inchikey": "HGCOOPLEWPBLOY-PFEQFJNWSA-N",
    "display_name": "ASCIMINIB HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e33001e7-3650-42b1-ae56-cddb5c43aa2b": {
      "match": "brand_token",
      "title": "SCEMBLIX (ASCIMINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "12",
      "published_date": "2025-12-05"
    }
  },
  "productid": "0078-1091_e187165a-eb84-4ee5-98b8-d4e777ec7b4a",
  "productndc": "0078-1091",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215358",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Oct 29, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Oct 29, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Apr 18, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ASCIMINIB HYDROCHLORIDE",
  "proprietary_name": "SCEMBLIX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215358",
  "marketing_category": "NDA",
  "nonproprietary_name": "asciminib",
  "start_marketing_date": "20211029",
  "active_numerator_strength": "20"
}