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United States · US · US:81643-9270_42039e70-fc10-450f-9dec-2b0402160bda

Floxuridine

Orange BookUNIISPLATC L01BC09

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

Identification

ManufacturerJND Therapeutics, Inc.
CountryUS (United States)
ATC codeL01BC09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8164392701
    1 VIAL in 1 BOX, UNIT-DOSE (81643-9270-1) / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)
039LU44I5M
FLOXURIDINE
RxCUI 4488
Orange Book
A075387
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "039LU44I5M",
    "rxcui": "4488",
    "inchikey": "ODKNJVUHOIMIIZ-RRKCRQDMSA-N",
    "display_name": "FLOXURIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTERIAL",
  "spl_meta": {
    "c8edabc1-67cd-421b-a147-7c1f19f05b8e": {
      "match": "brand_token",
      "title": "FLOXURIDINE (FLOXURIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "4",
      "published_date": "2024-10-21"
    }
  },
  "productid": "81643-9270_42039e70-fc10-450f-9dec-2b0402160bda",
  "productndc": "81643-9270",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "075387",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Apr 16, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLOXURIDINE",
  "proprietary_name": "Floxuridine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075387",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Floxuridine",
  "start_marketing_date": "20220609",
  "active_numerator_strength": "500"
}

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