Package 58468-0200-1

Brand: lemtrada

Generic: alemtuzumab
NDC Package

Package Facts

Identity

Package NDC 58468-0200-1
Digits Only 5846802001
Product NDC 58468-0200
Description

1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1) / 1.2 mL in 1 VIAL, SINGLE-USE

Marketing

Marketing Status
Marketed Since 2014-11-18
Brand lemtrada
Generic alemtuzumab
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "e9b870b2-1ea2-433f-991a-721c3cf582b1", "openfda": {"nui": ["N0000175079", "N0000175659"], "unii": ["3A189DH42V"], "rxcui": ["1594658", "1594663"], "spl_set_id": ["6236b0bc-82e9-4447-9a78-f57d94770269"], "pharm_class_epc": ["CD52-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD52-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1)  / 1.2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "58468-0200-1", "marketing_start_date": "20141118"}], "brand_name": "LEMTRADA", "product_id": "58468-0200_e9b870b2-1ea2-433f-991a-721c3cf582b1", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["CD52-directed Antibody Interactions [MoA]", "CD52-directed Cytolytic Antibody [EPC]"], "product_ndc": "58468-0200", "generic_name": "ALEMTUZUMAB", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEMTRADA", "active_ingredients": [{"name": "ALEMTUZUMAB", "strength": "12 mg/1.2mL"}], "application_number": "BLA103948", "marketing_category": "BLA", "marketing_start_date": "20141118", "listing_expiration_date": "20261231"}