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United States · US · US:62856-704_980cbc09-76e3-4b8f-a8c4-d8adf6743b55

Lenvima

Orange BookUNIISPLATC L01EX08

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

Identification

ManufacturerEisai Inc.
CountryUS (United States)
ATC codeL01EX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6285670430
    6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-704-30) / 5 CAPSULE in 1 BLISTER PACK (62856-704-05)

Annotations

UNII (FDA Substance ID)
EE083865G2
LENVATINIB
RxCUI 1603296
Orange Book
N206947
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "EE083865G2",
    "rxcui": "1603296",
    "inchikey": "WOSKHXYHFSIKNG-UHFFFAOYSA-N",
    "display_name": "LENVATINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f4bedd21-efde-44c6-9d9c-b48b78d7ed1e": {
      "match": "brand_token",
      "title": "LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]",
      "spl_version": "78",
      "published_date": "2025-06-06"
    }
  },
  "productid": "62856-704_980cbc09-76e3-4b8f-a8c4-d8adf6743b55",
  "productndc": "62856-704",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206947",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Feb 13, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Feb 13, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LENVATINIB",
  "proprietary_name": "Lenvima",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA206947",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lenvatinib",
  "start_marketing_date": "20180815",
  "active_numerator_strength": "4"
}

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