Package 58468-0051-1

Brand: xenpozyme

Generic: olipudase alfa-rpcp
NDC Package

Package Facts

Identity

Package NDC 58468-0051-1
Digits Only 5846800511
Product NDC 58468-0051
Description

1 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2022-08-29
Brand xenpozyme
Generic olipudase alfa-rpcp
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "ce8d4153-ce95-43c4-9672-e1e951ebcdaa", "openfda": {"unii": ["6D5766Q4OP"], "rxcui": ["2610411", "2610416", "2634357", "2634359"], "spl_set_id": ["01a910ee-a33e-4be3-ac41-322d64c34311"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (58468-0051-1)  / 1.1 mL in 1 VIAL", "package_ndc": "58468-0051-1", "marketing_start_date": "20220829"}], "brand_name": "XENPOZYME", "product_id": "58468-0051_ce8d4153-ce95-43c4-9672-e1e951ebcdaa", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "58468-0051", "generic_name": "olipudase alfa-rpcp", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XENPOZYME", "active_ingredients": [{"name": "OLIPUDASE ALFA", "strength": "4 mg/1.1mL"}], "application_number": "BLA761261", "marketing_category": "BLA", "marketing_start_date": "20220829", "listing_expiration_date": "20261231"}