🇺🇸
United States · US · US:49315-003_a6a1f86a-61c0-4769-8f6a-2b7af01c1410
CLOFARABINE
Orange BookUNIISPLATC L01BB06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeL01BB06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1149315003061 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 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": "49315-003_a6a1f86a-61c0-4769-8f6a-2b7af01c1410",
"productndc": "49315-003",
"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
Other records sharing ATC code L01BB06.
- 🇺🇸ClofarabineDr.Reddy's Laboratories Inc
- 🇺🇸ClofarabineAmneal Pharmaceuticals LLC
- 🇺🇸ClofarabineGland Pharma Limited
- 🇺🇸ClofarabineMeitheal Pharmaceuticals Inc.
- 🇺🇸CLOFARABINEFresenius Kabi USA, LLC
- 🇺🇸CLOFARABINEFosun Pharma USA Inc.
- 🇺🇸CLOFARABINEEugia US LLC
- GBClofarabine 20mg/20ml concentrate for solution for infusion vialsTeva UK Ltd
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