🇺🇸
United States · US · US:68083-386_e35a63ca-af60-4142-a5af-37640734e820
Clofarabine
Orange BookUNIISPLATC L01BB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeL01BB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083386011 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) / 20 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
762RDY0Y2H
CLOFARABINE
RxCUI 44151
Orange Book
A207831
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": "68083-386_e35a63ca-af60-4142-a5af-37640734e820",
"productndc": "68083-386",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "207831",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/20ML (1MG/ML)",
"product_no": "001",
"approval_date": "Oct 31, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOFARABINE",
"proprietary_name": "Clofarabine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA207831",
"marketing_category": "ANDA",
"nonproprietary_name": "Clofarabine",
"start_marketing_date": "20181114",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code L01BB06.
- 🇺🇸ClofarabineMeitheal Pharmaceuticals Inc.
- 🇺🇸ClofarabineAmneal Pharmaceuticals LLC
- 🇺🇸ClofarabineDr.Reddy's Laboratories Inc
- 🇺🇸CLOFARABINEFresenius Kabi USA, LLC
- 🇺🇸CLOFARABINEZydus Lifesciences Limited
- 🇺🇸CLOFARABINEFosun Pharma USA Inc.
- 🇺🇸CLOFARABINEEugia US LLC
- GBClofarabine 20mg/20ml concentrate for solution for infusion vialsTeva UK Ltd
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