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United States · US · US:70255-010_36941d95-638d-4a3c-8888-209eea0e0722
MEKTOVI
Orange BookUNIISPLATC L01EE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerArray BioPharma Inc.
CountryUS (United States)
ATC codeL01EE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170255010021 BOTTLE in 1 CARTON (70255-010-02) / 180 TABLET, FILM COATED in 1 BOTTLE
- ndc11702550100390 TABLET, FILM COATED in 1 BOTTLE (70255-010-03)
Annotations
UNII (FDA Substance ID)
181R97MR71
BINIMETINIB
RxCUI 2049122
Orange Book
N210498
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "181R97MR71",
"rxcui": "2049122",
"inchikey": "ACWZRVQXLIRSDF-UHFFFAOYSA-N",
"display_name": "BINIMETINIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6c3408ac-d401-4925-8a03-26591afbc240": {
"match": "brand_token",
"title": "MEKTOVI (BINIMETINIB) TABLET, FILM COATED [ARRAY BIOPHARMA INC.]",
"spl_version": "12",
"published_date": "2025-03-24"
}
},
"productid": "70255-010_36941d95-638d-4a3c-8888-209eea0e0722",
"productndc": "70255-010",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210498",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "15MG",
"product_no": "001",
"approval_date": "Jun 27, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BINIMETINIB",
"proprietary_name": "MEKTOVI",
"active_ingred_unit": "mg/1",
"application_number": "NDA210498",
"marketing_category": "NDA",
"nonproprietary_name": "BINIMETINIB",
"start_marketing_date": "20180627",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code L01EE03.
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