nelarabine

Generic: nelarabine

Labeler: meitheal pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nelarabine
Generic Name nelarabine
Labeler meitheal pharmaceuticals inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nelarabine 5 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 71288-165
Product ID 71288-165_6e728854-7685-4806-8edb-e2a3fc055c7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216038
Listing Expiration 2026-12-31
Marketing Start 2023-01-10

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 71288165
Hyphenated Format 71288-165

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 ANDA216038 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52)
source: ndc

Packages (1)

71288-165-54 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52)

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": "6e728854-7685-4806-8edb-e2a3fc055c7d", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["60158CV180"], "rxcui": ["603566"], "spl_set_id": ["21919314-5c25-49ab-beba-099983ed4a71"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54)  / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52)", "package_ndc": "71288-165-54", "marketing_start_date": "20230110"}], "brand_name": "Nelarabine", "product_id": "71288-165_6e728854-7685-4806-8edb-e2a3fc055c7d", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "71288-165", "generic_name": "Nelarabine", "labeler_name": "Meitheal Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nelarabine", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "ANDA216038", "marketing_category": "ANDA", "marketing_start_date": "20230110", "listing_expiration_date": "20261231"}