Package 0054-0906-23

Brand: sapropterin dihydrochloride

Generic: sapropterin dihydrochloride
NDC Package

Package Facts

Identity

Package NDC 0054-0906-23
Digits Only 0054090623
Product NDC 0054-0906
Product ID 0054-0906_d61800d3-94cc-46ce-8687-b467c63ac9fa
Description

120 TABLET in 1 BOTTLE (0054-0906-23)

Marketing

Marketing Status
Marketed Since 2025-10-23
Brand sapropterin dihydrochloride
Generic sapropterin dihydrochloride
Sample Package No

Linked Drug Pages (1)

sapropterin dihydrochloride ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d61800d3-94cc-46ce-8687-b467c63ac9fa", "openfda": {"unii": ["RG277LF5B3"], "rxcui": ["1486687"], "spl_set_id": ["c4d92cce-e899-4f14-b19c-5e17f9922215"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (0054-0906-23)", "package_ndc": "0054-0906-23", "marketing_start_date": "20251023"}], "brand_name": "sapropterin dihydrochloride", "product_id": "0054-0906_d61800d3-94cc-46ce-8687-b467c63ac9fa", "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": "0054-0906", "generic_name": "sapropterin dihydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sapropterin dihydrochloride", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA218797", "marketing_category": "ANDA", "marketing_start_date": "20251023", "listing_expiration_date": "20261231"}