nelarabine

Generic: nelarabine

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

Drug Facts

Product Profile

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

nelarabine 5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-233
Product ID 68083-233_a8747c60-a869-4e8b-ad3a-270dfc118180
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212605
Listing Expiration 2026-12-31
Marketing Start 2024-01-03

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 68083233
Hyphenated Format 68083-233

Supplemental Identifiers

RxCUI
603566
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 nelarabine (source: ndc)
Generic Name nelarabine (source: ndc)
Application Number ANDA212605 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 6 VIAL, SINGLE-DOSE in 1 CARTON (68083-233-06) / 50 mL in 1 VIAL, SINGLE-DOSE (68083-233-01)
source: ndc

Packages (1)

68083-233-06 6 VIAL, SINGLE-DOSE in 1 CARTON (68083-233-06) / 50 mL in 1 VIAL, SINGLE-DOSE (68083-233-01)

Ingredients (1)

nelarabine (5 mg/mL)

Linked Drug Pages (1)

Nelarabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a8747c60-a869-4e8b-ad3a-270dfc118180", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["60158CV180"], "rxcui": ["603566"], "spl_set_id": ["651bf4d2-75b0-4a60-8014-7006ffe61084"], "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": "6 VIAL, SINGLE-DOSE in 1 CARTON (68083-233-06)  / 50 mL in 1 VIAL, SINGLE-DOSE (68083-233-01)", "package_ndc": "68083-233-06", "marketing_start_date": "20240103"}], "brand_name": "Nelarabine", "product_id": "68083-233_a8747c60-a869-4e8b-ad3a-270dfc118180", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "68083-233", "generic_name": "Nelarabine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nelarabine", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "ANDA212605", "marketing_category": "ANDA", "marketing_start_date": "20240103", "listing_expiration_date": "20261231"}