arranon

Generic: nelarabine

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name arranon
Generic Name nelarabine
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nelarabine 5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 66758-165
Product ID 66758-165_fb10ca90-4391-4677-aaf6-cb696c198b4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021877
Listing Expiration 2026-12-31
Marketing Start 2016-10-05

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 66758165
Hyphenated Format 66758-165

Supplemental Identifiers

RxCUI
603566 616366
UPC
0366758165942
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
  • 6 VIAL in 1 CARTON (66758-165-86) / 50 mL in 1 VIAL (66758-165-94)
source: ndc

Packages (1)

66758-165-86 6 VIAL in 1 CARTON (66758-165-86) / 50 mL in 1 VIAL (66758-165-94)

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": "fb10ca90-4391-4677-aaf6-cb696c198b4f", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0366758165942"], "unii": ["60158CV180"], "rxcui": ["603566", "616366"], "spl_set_id": ["0f9051de-5c4d-4c0f-8c19-e15214498cca"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL in 1 CARTON (66758-165-86)  / 50 mL in 1 VIAL (66758-165-94)", "package_ndc": "66758-165-86", "marketing_start_date": "20250905"}], "brand_name": "Arranon", "product_id": "66758-165_fb10ca90-4391-4677-aaf6-cb696c198b4f", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "66758-165", "generic_name": "nelarabine", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arranon", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "NDA021877", "marketing_category": "NDA", "marketing_start_date": "20161005", "listing_expiration_date": "20261231"}