Package 68135-020-01

Brand: naglazyme

Generic: galsulfase
NDC Package

Package Facts

Identity

Package NDC 68135-020-01
Digits Only 6813502001
Product NDC 68135-020
Product ID 68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363
Description

1 VIAL in 1 CARTON (68135-020-01) / 5 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2005-06-09
Brand naglazyme
Generic galsulfase
Sample Package No

Linked Drug Pages (1)

NAGLAZYME ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "02482a8a-8333-4e9c-a9dc-ff7780f40363", "openfda": {"nui": ["M0000794", "N0000175823"], "unii": ["59UA429E5G"], "rxcui": ["578037", "584222"], "spl_set_id": ["59341250-deac-ed71-3823-a4f5d64dbd77"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68135-020-01)  / 5 mL in 1 VIAL", "package_ndc": "68135-020-01", "marketing_start_date": "20050609"}], "brand_name": "NAGLAZYME", "product_id": "68135-020_02482a8a-8333-4e9c-a9dc-ff7780f40363", "dosage_form": "SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "68135-020", "generic_name": "galsulfase", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NAGLAZYME", "active_ingredients": [{"name": "GALSULFASE", "strength": "5 mg/5mL"}], "application_number": "BLA125117", "marketing_category": "BLA", "marketing_start_date": "20050609", "listing_expiration_date": "20261231"}