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United States · US · US:62856-714_980cbc09-76e3-4b8f-a8c4-d8adf6743b55

Lenvima

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    6285671430
    6 BLISTER PACK in 1 BOX (62856-714-30) / 1 KIT in 1 BLISTER PACK (62856-714-05)

Annotations

Orange Book
N206947
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "62856-714_980cbc09-76e3-4b8f-a8c4-d8adf6743b55",
  "productndc": "62856-714",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Lenvima",
  "active_ingred_unit": null,
  "application_number": "NDA206947",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lenvatinib",
  "start_marketing_date": "20150213",
  "active_numerator_strength": null
}

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