arranon

Generic: nelarabine

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name arranon
Generic Name nelarabine
Labeler novartis pharmaceuticals corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nelarabine 5 mg/mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0683
Product ID 0078-0683_b1a3f864-56e1-44da-b2d0-7158d0945513
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021877
Marketing Start 2016-10-05
Marketing End 2026-09-30

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 00780683
Hyphenated Format 0078-0683

Supplemental Identifiers

RxCUI
603566 616366
UNII
60158CV180
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 arranon (source: ndc)
Generic Name nelarabine (source: ndc)
Application Number NDA021877 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 50 mL in 1 VIAL (0078-0683-61)
source: ndc

Packages (1)

0078-0683-61 50 mL in 1 VIAL (0078-0683-61)

Ingredients (1)

nelarabine (5 mg/mL)

Linked Drug Pages (1)

Arranon ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b1a3f864-56e1-44da-b2d0-7158d0945513", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["60158CV180"], "rxcui": ["603566", "616366"], "spl_set_id": ["fffa5d75-0dba-4ad7-a252-5f60fa28489a"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL (0078-0683-61)", "package_ndc": "0078-0683-61", "marketing_end_date": "20260930", "marketing_start_date": "20190802"}], "brand_name": "Arranon", "product_id": "0078-0683_b1a3f864-56e1-44da-b2d0-7158d0945513", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "0078-0683", "generic_name": "nelarabine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arranon", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "NDA021877", "marketing_category": "NDA", "marketing_end_date": "20260930", "marketing_start_date": "20161005"}