SCEMBLIX

Orange BookUNIISPLATC L01EA06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeL01EA06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078119620
60 TABLET, FILM COATED in 1 BOTTLE (0078-1196-20)

Annotations

UNII (FDA Substance ID)

C5U34S9XFV

ASCIMINIB HYDROCHLORIDE

RxCUI 2584303

Orange Book

N215358

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "0078-1196_e187165a-eb84-4ee5-98b8-d4e777ec7b4a",
  "productndc": "0078-1196",
  "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": "100"
}

Related drugs

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