nelarabine

Generic: nelarabine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nelarabine
Generic Name nelarabine
Labeler alembic pharmaceuticals limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nelarabine 5 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-813
Product ID 46708-813_482d7978-12a5-467a-b10e-1789df5dd0f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218554
Listing Expiration 2026-12-31
Marketing Start 2024-08-01

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 46708813
Hyphenated Format 46708-813

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 ANDA218554 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (46708-813-50) / 50 mL in 1 VIAL
  • 6 VIAL in 1 CARTON (46708-813-63) / 50 mL in 1 VIAL
source: ndc

Packages (2)

46708-813-50 1 VIAL in 1 CARTON (46708-813-50) / 50 mL in 1 VIAL 46708-813-63 6 VIAL in 1 CARTON (46708-813-63) / 50 mL in 1 VIAL

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": "482d7978-12a5-467a-b10e-1789df5dd0f8", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["60158CV180"], "rxcui": ["603566"], "spl_set_id": ["03ad6056-0e71-4e7c-842a-a5f87649bdcd"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (46708-813-50)  / 50 mL in 1 VIAL", "package_ndc": "46708-813-50", "marketing_start_date": "20240801"}, {"sample": false, "description": "6 VIAL in 1 CARTON (46708-813-63)  / 50 mL in 1 VIAL", "package_ndc": "46708-813-63", "marketing_start_date": "20240801"}], "brand_name": "NELARABINE", "product_id": "46708-813_482d7978-12a5-467a-b10e-1789df5dd0f8", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "46708-813", "generic_name": "nelarabine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NELARABINE", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "ANDA218554", "marketing_category": "ANDA", "marketing_start_date": "20240801", "listing_expiration_date": "20261231"}