TABRECTA

Orange BookUNIISPLATC L01EX17

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeL01EX17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0078071656
56 TABLET, FILM COATED in 1 BOTTLE (0078-0716-56)
ndc11
0078071694
56 TABLET, FILM COATED in 1 BOTTLE (0078-0716-94)

Annotations

UNII (FDA Substance ID)

C2A374O70X

CAPMATINIB HYDROCHLORIDE

RxCUI 2362259

Orange Book

N213591

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "C2A374O70X",
    "rxcui": "2362259",
    "inchikey": "COWBUPJEEDYWKD-UHFFFAOYSA-N",
    "display_name": "CAPMATINIB HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "455892c3-d144-4ba8-9ab4-79cabff9876d": {
      "match": "brand_token",
      "title": "TABRECTA (CAPMATINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "17",
      "published_date": "2025-12-16"
    }
  },
  "productid": "0078-0716_0df064bb-358d-4c21-8525-9b8b9a5845a1",
  "productndc": "0078-0716",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213591",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "May 6, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "May 6, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CAPMATINIB HYDROCHLORIDE",
  "proprietary_name": "TABRECTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213591",
  "marketing_category": "NDA",
  "nonproprietary_name": "capmatinib",
  "start_marketing_date": "20200506",
  "active_numerator_strength": "200"
}

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