Package 68135-482-11

Brand: kuvan

Generic: sapropterin dihydrochloride
NDC Package

Package Facts

Identity

Package NDC 68135-482-11
Digits Only 6813548211
Product NDC 68135-482
Product ID 68135-482_c4286a54-6e01-4444-94a0-943411790e1d
Description

30 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10)

Marketing

Marketing Status
Marketed Since 2015-05-27
Brand kuvan
Generic sapropterin dihydrochloride
Sample Package No

Linked Drug Pages (1)

Kuvan ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c4286a54-6e01-4444-94a0-943411790e1d", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1111018", "1111020", "1486687", "1486691", "1653217", "1653221"], "spl_set_id": ["af38711e-8873-4790-a92d-4d583e23fb89"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (68135-482-11)  / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10)", "package_ndc": "68135-482-11", "marketing_start_date": "20150527"}], "brand_name": "Kuvan", "product_id": "68135-482_c4286a54-6e01-4444-94a0-943411790e1d", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Phenylalanine Hydroxylase Activator [EPC]", "Phenylalanine Hydroxylase Activators [MoA]"], "product_ndc": "68135-482", "generic_name": "sapropterin dihydrochloride", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kuvan", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "NDA205065", "marketing_category": "NDA", "marketing_start_date": "20150527", "listing_expiration_date": "20261231"}