clofarabine

Generic: clofarabine

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clofarabine
Generic Name clofarabine
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

clofarabine 1 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-326
Product ID 55150-326_18adf4af-63ed-41e6-ab59-87085ce3e5fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212457
Listing Expiration 2026-12-31
Marketing Start 2022-10-03

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 55150326
Hyphenated Format 55150-326

Supplemental Identifiers

RxCUI
486419
UPC
0355150326013
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 ANDA212457 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-326-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-326-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-326-01) / 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": "18adf4af-63ed-41e6-ab59-87085ce3e5fb", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0355150326013"], "unii": ["762RDY0Y2H"], "rxcui": ["486419"], "spl_set_id": ["18adf4af-63ed-41e6-ab59-87085ce3e5fb"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-326-01)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-326-01", "marketing_start_date": "20221003"}], "brand_name": "CLOFARABINE", "product_id": "55150-326_18adf4af-63ed-41e6-ab59-87085ce3e5fb", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "55150-326", "generic_name": "CLOFARABINE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOFARABINE", "active_ingredients": [{"name": "CLOFARABINE", "strength": "1 mg/mL"}], "application_number": "ANDA212457", "marketing_category": "ANDA", "marketing_start_date": "20221003", "listing_expiration_date": "20261231"}