Package 54092-700-01

Brand: elaprase

Generic: idursulfase
NDC Package

Package Facts

Identity

Package NDC 54092-700-01
Digits Only 5409270001
Product NDC 54092-700
Description

1 VIAL, GLASS in 1 BOX (54092-700-01) / 3 mL in 1 VIAL, GLASS

Marketing

Marketing Status
Marketed Since 2006-07-24
Brand elaprase
Generic idursulfase
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "25f45811-e646-4342-9954-d8220cadf886", "openfda": {"nui": ["M0000794", "N0000175823"], "unii": ["5W8JGG2651"], "rxcui": ["644104", "647118"], "spl_set_id": ["60cba843-5aab-4dd7-96dc-66648d413be3"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 BOX (54092-700-01)  / 3 mL in 1 VIAL, GLASS", "package_ndc": "54092-700-01", "marketing_start_date": "20060724"}], "brand_name": "ELAPRASE", "product_id": "54092-700_25f45811-e646-4342-9954-d8220cadf886", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "54092-700", "generic_name": "idursulfase", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELAPRASE", "active_ingredients": [{"name": "IDURSULFASE", "strength": "6 mg/3mL"}], "application_number": "BLA125151", "marketing_category": "BLA", "marketing_start_date": "20060724", "listing_expiration_date": "20261231"}