nelarabine

Generic: nelarabine

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nelarabine
Generic Name nelarabine
Labeler zydus pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nelarabine 5 mg/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1839
Product ID 70710-1839_a144ddba-18cc-441e-942e-4170b34d4a3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215037
Listing Expiration 2026-12-31
Marketing Start 2022-06-24

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 707101839
Hyphenated Format 70710-1839

Supplemental Identifiers

RxCUI
603566
UPC
0370710183912
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 ANDA215037 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-1) / 50 mL in 1 VIAL, SINGLE-DOSE
  • 6 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-8) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

70710-1839-1 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-1) / 50 mL in 1 VIAL, SINGLE-DOSE 70710-1839-8 6 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-8) / 50 mL in 1 VIAL, SINGLE-DOSE

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": "a144ddba-18cc-441e-942e-4170b34d4a3e", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0370710183912"], "unii": ["60158CV180"], "rxcui": ["603566"], "spl_set_id": ["8cb23281-93ca-40b8-b8e0-c57dd4298322"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-1)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70710-1839-1", "marketing_start_date": "20220624"}, {"sample": false, "description": "6 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-8)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70710-1839-8", "marketing_start_date": "20220624"}], "brand_name": "Nelarabine", "product_id": "70710-1839_a144ddba-18cc-441e-942e-4170b34d4a3e", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "70710-1839", "generic_name": "Nelarabine", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nelarabine", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "ANDA215037", "marketing_category": "ANDA", "marketing_start_date": "20220624", "listing_expiration_date": "20261231"}