Package 31722-045-12
Brand: sapropterin dihydrochloride
Generic: sapropterin dihydrochloridePackage Facts
Identity
Package NDC
31722-045-12
Digits Only
3172204512
Product NDC
31722-045
Description
120 TABLET in 1 BOTTLE (31722-045-12)
Marketing
Marketing Status
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": "4b91366e-4989-50aa-e063-6294a90ac65f", "openfda": {"upc": ["0331722045124"], "unii": ["RG277LF5B3"], "rxcui": ["1486687"], "spl_set_id": ["ec8ea96c-8ec1-4301-a85d-d59562e548ca"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (31722-045-12)", "package_ndc": "31722-045-12", "marketing_start_date": "20220823"}], "brand_name": "sapropterin dihydrochloride", "product_id": "31722-045_4b91366e-4989-50aa-e063-6294a90ac65f", "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": "31722-045", "generic_name": "sapropterin dihydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sapropterin dihydrochloride", "active_ingredients": [{"name": "SAPROPTERIN DIHYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA215534", "marketing_category": "ANDA", "marketing_start_date": "20220823", "listing_expiration_date": "20271231"}