Package 68135-100-01

Brand: vimizim

Generic: elosulfase alfa
NDC Package

Package Facts

Identity

Package NDC 68135-100-01
Digits Only 6813510001
Product NDC 68135-100
Product ID 68135-100_d3f50b07-ab7c-4922-83b5-6441be0c3c11
Description

1 VIAL in 1 CARTON (68135-100-01) / 5 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2014-02-14
Brand vimizim
Generic elosulfase alfa
Sample Package No

Linked Drug Pages (1)

VIMIZIM ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d3f50b07-ab7c-4922-83b5-6441be0c3c11", "openfda": {"nui": ["M0000794", "N0000175823"], "unii": ["ODJ69JZG85"], "rxcui": ["1490047", "1490052"], "spl_set_id": ["0caa2565-12b2-0ad0-1f9a-273e81c3d4cc"], "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 (68135-100-01)  / 5 mL in 1 VIAL", "package_ndc": "68135-100-01", "marketing_start_date": "20140214"}], "brand_name": "VIMIZIM", "product_id": "68135-100_d3f50b07-ab7c-4922-83b5-6441be0c3c11", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]", "alpha-Glucosidases [CS]"], "product_ndc": "68135-100", "generic_name": "elosulfase alfa", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIMIZIM", "active_ingredients": [{"name": "ELOSULFASE ALFA", "strength": "5 mg/5mL"}], "application_number": "BLA125460", "marketing_category": "BLA", "marketing_start_date": "20140214", "listing_expiration_date": "20261231"}