clofarabine

Generic: clofarabine

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clofarabine
Generic Name clofarabine
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

clofarabine 1 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-128
Product ID 71288-128_06e3bdb0-c175-4e35-a15e-2779a54004ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213461
Listing Expiration 2026-12-31
Marketing Start 2020-10-23

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 71288128
Hyphenated Format 71288-128

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 ANDA213461 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-128-20) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-128-20 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-128-20) / 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": "06e3bdb0-c175-4e35-a15e-2779a54004ea", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["762RDY0Y2H"], "rxcui": ["486419"], "spl_set_id": ["54436453-882e-406b-87a3-049d150101c6"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-128-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-128-20", "marketing_start_date": "20201023"}], "brand_name": "Clofarabine", "product_id": "71288-128_06e3bdb0-c175-4e35-a15e-2779a54004ea", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "71288-128", "generic_name": "Clofarabine", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clofarabine", "active_ingredients": [{"name": "CLOFARABINE", "strength": "1 mg/mL"}], "application_number": "ANDA213461", "marketing_category": "ANDA", "marketing_start_date": "20201023", "listing_expiration_date": "20261231"}