clofarabine

Generic: clofarabine

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clofarabine
Generic Name clofarabine
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

clofarabine 1 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-546
Product ID 67457-546_91ccea15-3700-4756-a4c6-e1121b95ef99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208860
Marketing Start 2017-11-06
Marketing End 2026-05-31

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457546
Hyphenated Format 67457-546

Supplemental Identifiers

RxCUI
486419
UNII
762RDY0Y2H
NUI
N0000000233 N0000175595

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clofarabine (source: ndc)
Generic Name clofarabine (source: ndc)
Application Number ANDA208860 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-546-20) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

67457-546-20 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-546-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

clofarabine (1 mg/mL)

Linked Drug Pages (1)

clofarabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "91ccea15-3700-4756-a4c6-e1121b95ef99", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["762RDY0Y2H"], "rxcui": ["486419"], "spl_set_id": ["1f8ac128-c25d-41f4-9f90-410a792acd66"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-546-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67457-546-20", "marketing_end_date": "20260531", "marketing_start_date": "20171106"}], "brand_name": "clofarabine", "product_id": "67457-546_91ccea15-3700-4756-a4c6-e1121b95ef99", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "67457-546", "generic_name": "clofarabine", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "clofarabine", "active_ingredients": [{"name": "CLOFARABINE", "strength": "1 mg/mL"}], "application_number": "ANDA208860", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20171106"}