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United States · US · US:0078-1161_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
- ndc11007811614790 mL in 1 BOTTLE (0078-1161-47)
Annotations
UNII (FDA Substance ID)
BSB9VJ5TUT
TRAMETINIB DIMETHYL SULFOXIDE
RxCUI 1425098
Orange Book
N217513
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": "0078-1161_235e3bc1-099b-4587-9d72-b02fcc3387d1",
"productndc": "0078-1161",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "217513",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.05MG BASE/ML",
"product_no": "001",
"approval_date": "Mar 16, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRAMETINIB DIMETHYL SULFOXIDE",
"proprietary_name": "Mekinist",
"active_ingred_unit": "mg/mL",
"application_number": "NDA217513",
"marketing_category": "NDA",
"nonproprietary_name": "trametinib",
"start_marketing_date": "20230316",
"active_numerator_strength": ".05"
}Related drugs
Other records sharing ATC code L01EE01.
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