clofarabine

Generic: clofarabine

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clofarabine
Generic Name clofarabine
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

clofarabine 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-386
Product ID 68083-386_e35a63ca-af60-4142-a5af-37640734e820
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207831
Listing Expiration 2026-12-31
Marketing Start 2018-11-14

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 68083386
Hyphenated Format 68083-386

Supplemental Identifiers

RxCUI
486419
UPC
0368083386016
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 ANDA207831 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-386-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) / 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": "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"}