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United States · US · US:63020-210_692e8d28-13e4-43ae-8ea9-f2de3bc73d06

Fruzaqla

Orange BookUNIISPLATC L01EK04

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeL01EK04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6302021021
    1 BOTTLE in 1 CARTON (63020-210-21) / 21 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
49DXG3M5ZW
FRUQUINTINIB
Orange Book
N217564
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "49DXG3M5ZW",
    "rxcui": null,
    "inchikey": "BALLNEJQLSTPIO-UHFFFAOYSA-N",
    "display_name": "FRUQUINTINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "186d786e-dc8a-45f2-b5e1-01ac0201879f": {
      "match": "brand_token",
      "title": "FRUZAQLA (FRUQUINTINIB) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "6",
      "published_date": "2026-02-24"
    }
  },
  "productid": "63020-210_692e8d28-13e4-43ae-8ea9-f2de3bc73d06",
  "productndc": "63020-210",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217564",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Nov 8, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Nov 8, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FRUQUINTINIB",
  "proprietary_name": "Fruzaqla",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217564",
  "marketing_category": "NDA",
  "nonproprietary_name": "fruquintinib",
  "start_marketing_date": "20231108",
  "active_numerator_strength": "1"
}

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