Package 58468-0426-1

Brand: nexviazyme

Generic: avalglucosidase alfa-ngpt
NDC Package

Package Facts

Identity

Package NDC 58468-0426-1
Digits Only 5846804261
Product NDC 58468-0426
Product ID 58468-0426_583725c8-1d65-4479-b93b-b945bfe8a39b
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (58468-0426-1) / 10 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2021-08-06
Brand nexviazyme
Generic avalglucosidase alfa-ngpt
Sample Package No

Linked Drug Pages (1)

Nexviazyme ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "583725c8-1d65-4479-b93b-b945bfe8a39b", "openfda": {"nui": ["M0000794", "N0000175821"], "unii": ["EO144CP0X9"], "rxcui": ["2565818", "2565823"], "spl_set_id": ["80eb3c9c-01d3-44fe-90ef-81df101b954d"], "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-DOSE in 1 CARTON (58468-0426-1)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "58468-0426-1", "marketing_start_date": "20210806"}], "brand_name": "Nexviazyme", "product_id": "58468-0426_583725c8-1d65-4479-b93b-b945bfe8a39b", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "58468-0426", "generic_name": "avalglucosidase alfa-ngpt", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nexviazyme", "active_ingredients": [{"name": "AVALGLUCOSIDASE ALFA", "strength": "100 mg/10mL"}], "application_number": "BLA761194", "marketing_category": "BLA", "marketing_start_date": "20210806", "listing_expiration_date": "20261231"}