Package 0009-5091-25

Brand: ellence

Generic: epirubicin hydrochloride
NDC Package

Package Facts

Identity

Package NDC 0009-5091-25
Digits Only 0009509125
Product NDC 0009-5091
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25) / 25 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2025-03-24
Brand ellence
Generic epirubicin hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "fb8fdcc7-9949-486f-a487-0eebd44cb40e", "openfda": {"unii": ["22966TX7J5"], "rxcui": ["1732182", "1732183", "1732186", "1732187"], "spl_set_id": ["0a03c798-a652-4895-b29c-3b521a89ba42"], "manufacturer_name": ["Pharmacia & Upjohn Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0009-5091-01", "marketing_start_date": "19990915"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0009-5091-25", "marketing_start_date": "20250324"}], "brand_name": "Ellence", "product_id": "0009-5091_fb8fdcc7-9949-486f-a487-0eebd44cb40e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anthracycline Topoisomerase Inhibitor [EPC]", "Anthracyclines [CS]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0009-5091", "generic_name": "epirubicin hydrochloride", "labeler_name": "Pharmacia & Upjohn Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ellence", "active_ingredients": [{"name": "EPIRUBICIN HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "NDA050778", "marketing_category": "NDA", "marketing_start_date": "19990915", "listing_expiration_date": "20261231"}