clofarabine

Generic: clofarabine

Labeler: dr.reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clofarabine
Generic Name clofarabine
Labeler dr.reddy's laboratories inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

clofarabine 1 mg/mL

Manufacturer
Dr.Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-309
Product ID 43598-309_eb98402e-1ef9-9930-20f2-3e3eb521cf9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205375
Listing Expiration 2026-12-31
Marketing Start 2017-11-08

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 43598309
Hyphenated Format 43598-309

Supplemental Identifiers

RxCUI
486419
UPC
0343598309200
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 ANDA205375 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-309-20) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

43598-309-20 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-309-20) / 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": "eb98402e-1ef9-9930-20f2-3e3eb521cf9a", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0343598309200"], "unii": ["762RDY0Y2H"], "rxcui": ["486419"], "spl_set_id": ["0da6764d-5fac-7e0f-ea3e-a5aee55a8b2d"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (43598-309-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "43598-309-20", "marketing_start_date": "20171108"}], "brand_name": "Clofarabine", "product_id": "43598-309_eb98402e-1ef9-9930-20f2-3e3eb521cf9a", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "43598-309", "generic_name": "Clofarabine", "labeler_name": "Dr.Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clofarabine", "active_ingredients": [{"name": "CLOFARABINE", "strength": "1 mg/mL"}], "application_number": "ANDA205375", "marketing_category": "ANDA", "marketing_start_date": "20171108", "listing_expiration_date": "20261231"}