Package 73289-0070-2
Brand: zelvysia
Generic: sapropterin dihydrochloridePackage Facts
Identity
Package NDC
73289-0070-2
Digits Only
7328900702
Product NDC
73289-0070
Description
30 PACKET in 1 CARTON (73289-0070-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1)
Marketing
Marketing Status
Brand
zelvysia
Generic
sapropterin dihydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "34007201-2d47-96fd-e063-6394a90a6327", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1111018", "1653217", "2712689", "2712691"], "spl_set_id": ["8de84882-dd24-46f2-8416-5e492d4275d1"], "manufacturer_name": ["Aucta Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (73289-0070-2) / 1 POWDER, FOR SOLUTION in 1 PACKET (73289-0070-1)", "package_ndc": "73289-0070-2", "marketing_start_date": "20250429"}], "brand_name": "ZELVYSIA", "product_id": "73289-0070_34007201-2d47-96fd-e063-6394a90a6327", "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": "73289-0070", "generic_name": "SAPROPTERIN DIHYDROCHLORIDE", "labeler_name": "Aucta Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZELVYSIA", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA218645", "marketing_category": "ANDA", "marketing_start_date": "20250429", "listing_expiration_date": "20261231"}