Package 58468-0041-1

Brand: fabrazyme

Generic: agalsidase beta
NDC Package

Package Facts

Identity

Package NDC 58468-0041-1
Digits Only 5846800411
Product NDC 58468-0041
Product ID 58468-0041_9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1
Description

1 VIAL, GLASS in 1 CARTON (58468-0041-1) / 1 mL in 1 VIAL, GLASS

Marketing

Marketing Status
Marketed Since 2008-12-17
Brand fabrazyme
Generic agalsidase beta
Sample Package No

Linked Drug Pages (1)

Fabrazyme ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1", "openfda": {"nui": ["M0000794", "N0000175822"], "unii": ["RZD65TSM9U"], "rxcui": ["1804755", "1804758", "1804760", "1804762"], "spl_set_id": ["988513ab-b06f-4dd0-93f7-d2d4531dcce4"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (58468-0041-1)  / 1 mL in 1 VIAL, GLASS", "package_ndc": "58468-0041-1", "marketing_start_date": "20081217"}], "brand_name": "Fabrazyme", "product_id": "58468-0041_9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "58468-0041", "generic_name": "AGALSIDASE BETA", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fabrazyme", "active_ingredients": [{"name": "AGALSIDASE BETA", "strength": "5 mg/mL"}], "application_number": "BLA103979", "marketing_category": "BLA", "marketing_start_date": "20081217", "listing_expiration_date": "20261231"}