clofarabine

Generic: clofarabine

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clofarabine
Generic Name clofarabine
Labeler zydus lifesciences limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

clofarabine 1 mg/mL

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 49315-003
Product ID 49315-003_a6a1f86a-61c0-4769-8f6a-2b7af01c1410
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204029
Listing Expiration 2026-12-31
Marketing Start 2017-05-10

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 49315003
Hyphenated Format 49315-003

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 ANDA204029 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 20 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

49315-003-06 1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 20 mL in 1 VIAL, SINGLE-USE

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": "a6a1f86a-61c0-4769-8f6a-2b7af01c1410", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["762RDY0Y2H"], "rxcui": ["486419"], "spl_set_id": ["4d8d8e81-01ba-4493-b458-7f6375c5bbae"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06)  / 20 mL in 1 VIAL, SINGLE-USE", "package_ndc": "49315-003-06", "marketing_start_date": "20170510"}], "brand_name": "CLOFARABINE", "product_id": "49315-003_a6a1f86a-61c0-4769-8f6a-2b7af01c1410", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "49315-003", "generic_name": "clofarabine", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOFARABINE", "active_ingredients": [{"name": "CLOFARABINE", "strength": "1 mg/mL"}], "application_number": "ANDA204029", "marketing_category": "ANDA", "marketing_start_date": "20170510", "listing_expiration_date": "20261231"}