nelarabine

Generic: nelarabine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nelarabine
Generic Name nelarabine
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nelarabine 5 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1743
Product ID 70121-1743_2a0e02cf-dd3d-4fb6-b9a3-dc29d1156c28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216346
Listing Expiration 2026-12-31
Marketing Start 2023-04-10

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 701211743
Hyphenated Format 70121-1743

Supplemental Identifiers

RxCUI
603566
UPC
0370121174318
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 ANDA216346 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE (70121-1743-1)
source: ndc

Packages (1)

70121-1743-4 6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE (70121-1743-1)

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": "2a0e02cf-dd3d-4fb6-b9a3-dc29d1156c28", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0370121174318"], "unii": ["60158CV180"], "rxcui": ["603566"], "spl_set_id": ["8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4)  / 50 mL in 1 VIAL, SINGLE-DOSE (70121-1743-1)", "package_ndc": "70121-1743-4", "marketing_start_date": "20230410"}], "brand_name": "Nelarabine", "product_id": "70121-1743_2a0e02cf-dd3d-4fb6-b9a3-dc29d1156c28", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "70121-1743", "generic_name": "Nelarabine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nelarabine", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "ANDA216346", "marketing_category": "ANDA", "marketing_start_date": "20230410", "listing_expiration_date": "20261231"}