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United States · US · US:71288-128_06e3bdb0-c175-4e35-a15e-2779a54004ea

Clofarabine

Orange BookUNIISPLATC L01BB06

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01BB06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7128812820
    1 VIAL, SINGLE-DOSE in 1 CARTON (71288-128-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
762RDY0Y2H
CLOFARABINE
RxCUI 44151
Orange Book
A213461
AP
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": "71288-128_06e3bdb0-c175-4e35-a15e-2779a54004ea",
  "productndc": "71288-128",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "213461",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/20ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 23, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOFARABINE",
  "proprietary_name": "Clofarabine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA213461",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clofarabine",
  "start_marketing_date": "20201023",
  "active_numerator_strength": "1"
}

Related drugs

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