Package 81927-375-01

Brand: nelarabine

Generic: nelarabine
NDC Package

Package Facts

Identity

Package NDC 81927-375-01
Digits Only 8192737501
Product NDC 81927-375
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (81927-375-01) / 75 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2025-08-31
Brand nelarabine
Generic nelarabine
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "f21b358e-9f41-4dc3-858f-b55f9a8af715", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0381927111018"], "unii": ["60158CV180"], "rxcui": ["603566", "2722411"], "spl_set_id": ["fc401b06-4e3b-413e-a854-3e031c433862"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Shorla Oncology Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (81927-375-01)  / 75 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "81927-375-01", "marketing_start_date": "20250831"}], "brand_name": "nelarabine", "product_id": "81927-375_f21b358e-9f41-4dc3-858f-b55f9a8af715", "dosage_form": "INJECTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "81927-375", "generic_name": "nelarabine", "labeler_name": "Shorla Oncology Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nelarabine", "active_ingredients": [{"name": "NELARABINE", "strength": "5 mg/mL"}], "application_number": "ANDA214809", "marketing_category": "ANDA", "marketing_start_date": "20250831", "listing_expiration_date": "20261231"}