Package 58468-0070-1

Brand: aldurazyme

Generic: laronidase
NDC Package

Package Facts

Identity

Package NDC 58468-0070-1
Digits Only 5846800701
Product NDC 58468-0070
Product ID 58468-0070_a6819483-3275-4b44-8e87-f6246503af43
Description

5 mL in 1 VIAL, GLASS (58468-0070-1)

Marketing

Marketing Status
Marketed Since 2003-04-30
Brand aldurazyme
Generic laronidase
Sample Package No

Linked Drug Pages (1)

ALDURAZYME ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a6819483-3275-4b44-8e87-f6246503af43", "openfda": {"nui": ["M0000794", "N0000175823"], "unii": ["WP58SVM6R4"], "rxcui": ["403822", "404492"], "spl_set_id": ["a80ac249-cae4-41f3-88bb-344088b20e60"], "pharm_class_cs": ["alpha-Glucosidases [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, GLASS (58468-0070-1)", "package_ndc": "58468-0070-1", "marketing_start_date": "20030430"}], "brand_name": "ALDURAZYME", "product_id": "58468-0070_a6819483-3275-4b44-8e87-f6246503af43", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "58468-0070", "generic_name": "laronidase", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALDURAZYME", "active_ingredients": [{"name": "LARONIDASE", "strength": "2.9 mg/5mL"}], "application_number": "BLA125058", "marketing_category": "BLA", "marketing_start_date": "20030430", "listing_expiration_date": "20261231"}