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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

  • ndc11
    7025501002
    1 BOTTLE in 1 CARTON (70255-010-02) / 180 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7025501003
    90 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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