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United States · US · US:63323-572_5d0113e4-7027-4908-a76d-46eac772e404

CLOFARABINE

Orange BookUNIISPLATC L01BB06

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01BB06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332357270
    1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) / 20 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
762RDY0Y2H
CLOFARABINE
RxCUI 44151
Orange Book
A204029
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "762RDY0Y2H",
    "rxcui": "44151",
    "inchikey": "WDDPHFBMKLOVOX-AYQXTPAHSA-N",
    "display_name": "CLOFARABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e956b1e0-2829-4872-8c09-99462d60e922": {
      "match": "brand_token",
      "title": "CLOFARABINE INJECTION [FOSUN PHARMA USA INC.]",
      "spl_version": "4",
      "published_date": "2025-01-10"
    }
  },
  "productid": "63323-572_5d0113e4-7027-4908-a76d-46eac772e404",
  "productndc": "63323-572",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "204029",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/20ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "May 9, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOFARABINE",
  "proprietary_name": "CLOFARABINE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA204029",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clofarabine",
  "start_marketing_date": "20170510",
  "active_numerator_strength": "1"
}

Related drugs

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