Back to search
🇺🇸

United States · US · US:70255-025_7dd6ed01-4c55-49ef-b55d-6d82c5dfc02e

BRAFTOVI

Orange BookUNIISPLATC L01EC03

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

Identification

ManufacturerArray BioPharma Inc.
CountryUS (United States)
ATC codeL01EC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7025502501
    2 BOTTLE in 1 CARTON (70255-025-01) / 90 CAPSULE in 1 BOTTLE (70255-025-02)
  • ndc11
    7025502503
    2 BOTTLE in 1 CARTON (70255-025-03) / 60 CAPSULE in 1 BOTTLE (70255-025-04)
  • ndc11
    7025502505
    90 CAPSULE in 1 BOTTLE (70255-025-05)
  • ndc11
    7025502506
    60 CAPSULE in 1 BOTTLE (70255-025-06)

Annotations

UNII (FDA Substance ID)
8L7891MRB6
ENCORAFENIB
RxCUI 2049106
Orange Book
N210496
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8L7891MRB6",
    "rxcui": "2049106",
    "inchikey": "CMJCXYNUCSMDBY-ZDUSSCGKSA-N",
    "display_name": "ENCORAFENIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "235dfc38-0f0b-4037-b501-7a9f4294740c": {
      "match": "brand_token",
      "title": "BRAFTOVI (ENCORAFENIB) CAPSULE [ARRAY BIOPHARMA INC.]",
      "spl_version": "23",
      "published_date": "2026-03-02"
    }
  },
  "productid": "70255-025_7dd6ed01-4c55-49ef-b55d-6d82c5dfc02e",
  "productndc": "70255-025",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210496",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 27, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "75MG",
        "product_no": "002",
        "approval_date": "Jun 27, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ENCORAFENIB",
  "proprietary_name": "BRAFTOVI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA210496",
  "marketing_category": "NDA",
  "nonproprietary_name": "Encorafenib",
  "start_marketing_date": "20180627",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code L01EC03.

Access this data programmatically

Query BRAFTOVI and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.