Package 68083-386-01
Brand: clofarabine
Generic: clofarabinePackage Facts
Identity
Package NDC
68083-386-01
Digits Only
6808338601
Product NDC
68083-386
Description
1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) / 20 mL in 1 VIAL, SINGLE-DOSE
Marketing
Marketing Status
Brand
clofarabine
Generic
clofarabine
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "e35a63ca-af60-4142-a5af-37640734e820", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0368083386016"], "unii": ["762RDY0Y2H"], "rxcui": ["486419"], "spl_set_id": ["b7d3a96e-0280-4f14-b921-795996f75950"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-386-01", "marketing_start_date": "20181114"}], "brand_name": "Clofarabine", "product_id": "68083-386_e35a63ca-af60-4142-a5af-37640734e820", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68083-386", "generic_name": "Clofarabine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clofarabine", "active_ingredients": [{"name": "CLOFARABINE", "strength": "1 mg/mL"}], "application_number": "ANDA207831", "marketing_category": "ANDA", "marketing_start_date": "20181114", "listing_expiration_date": "20261231"}