Package 58468-0160-1

Brand: lumizyme

Generic: alglucosidase alfa
NDC Package

Package Facts

Identity

Package NDC 58468-0160-1
Digits Only 5846801601
Product NDC 58468-0160
Product ID 58468-0160_26b8bca9-7139-453b-afaa-2474ca711fc2
Description

1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) / 10.5 mL in 1 VIAL, SINGLE-USE

Marketing

Marketing Status
Marketed Since 2010-05-24
Brand lumizyme
Generic alglucosidase alfa
Sample Package No

Linked Drug Pages (1)

Lumizyme ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "26b8bca9-7139-453b-afaa-2474ca711fc2", "openfda": {"nui": ["M0000794", "N0000175821"], "unii": ["DTI67O9503"], "rxcui": ["629568", "993072"], "spl_set_id": ["d6bfbc45-2d34-439e-8aad-59ee2d53d4df"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1)  / 10.5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "58468-0160-1", "marketing_start_date": "20100524"}], "brand_name": "Lumizyme", "product_id": "58468-0160_26b8bca9-7139-453b-afaa-2474ca711fc2", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "58468-0160", "generic_name": "ALGLUCOSIDASE ALFA", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lumizyme", "active_ingredients": [{"name": "ALGLUCOSIDASE ALFA", "strength": "5 mg/mL"}], "application_number": "BLA125291", "marketing_category": "BLA", "marketing_start_date": "20100524", "listing_expiration_date": "20261231"}