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United States · US · US:0078-1105_235e3bc1-099b-4587-9d72-b02fcc3387d1

Mekinist

Orange BookUNIISPLATC L01EE01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078110515
    30 TABLET, FILM COATED in 1 BOTTLE (0078-1105-15)

Annotations

UNII (FDA Substance ID)
BSB9VJ5TUT
TRAMETINIB DIMETHYL SULFOXIDE
RxCUI 1425098
Orange Book
N204114
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "BSB9VJ5TUT",
    "rxcui": "1425098",
    "inchikey": "OQUFJVRYDFIQBW-UHFFFAOYSA-N",
    "display_name": "TRAMETINIB DIMETHYL SULFOXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0002ad27-779d-42ab-83b5-bc65453412a1": {
      "match": "brand_token",
      "title": "MEKINIST (TRAMETINIB) TABLET, FILM COATED MEKINIST (TRAMETINIB) POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "35",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0078-1105_235e3bc1-099b-4587-9d72-b02fcc3387d1",
  "productndc": "0078-1105",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204114",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.5MG",
        "product_no": "001",
        "approval_date": "May 29, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "May 29, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG",
        "product_no": "003",
        "approval_date": "May 29, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRAMETINIB DIMETHYL SULFOXIDE",
  "proprietary_name": "Mekinist",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204114",
  "marketing_category": "NDA",
  "nonproprietary_name": "trametinib",
  "start_marketing_date": "20160317",
  "active_numerator_strength": ".5"
}

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