Package 59651-574-08

Brand: sapropterin dihydrochloride

Generic: sapropterin dihydrochloride
NDC Package

Package Facts

Identity

Package NDC 59651-574-08
Digits Only 5965157408
Product NDC 59651-574
Description

120 TABLET in 1 BOTTLE (59651-574-08)

Marketing

Marketing Status
Marketed Since 2025-06-09
Brand sapropterin dihydrochloride
Generic sapropterin dihydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "11ee25bc-f501-4f9d-b63d-63b2eee0147e", "openfda": {"upc": ["0359651574300"], "unii": ["RG277LF5B3"], "rxcui": ["1486687"], "spl_set_id": ["11ee25bc-f501-4f9d-b63d-63b2eee0147e"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (59651-574-08)", "package_ndc": "59651-574-08", "marketing_start_date": "20250609"}, {"sample": false, "description": "240 TABLET in 1 BOTTLE (59651-574-24)", "package_ndc": "59651-574-24", "marketing_start_date": "20250609"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (59651-574-30)", "package_ndc": "59651-574-30", "marketing_start_date": "20250609"}], "brand_name": "Sapropterin Dihydrochloride", "product_id": "59651-574_11ee25bc-f501-4f9d-b63d-63b2eee0147e", "dosage_form": "TABLET", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Phenylalanine Hydroxylase Activator [EPC]", "Phenylalanine Hydroxylase Activators [MoA]"], "product_ndc": "59651-574", "generic_name": "Sapropterin Dihydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sapropterin Dihydrochloride", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA216797", "marketing_category": "ANDA", "marketing_start_date": "20250609", "listing_expiration_date": "20261231"}