Package 70709-112-60

Brand: harliku

Generic: nitisinone
NDC Package

Package Facts

Identity

Package NDC 70709-112-60
Digits Only 7070911260
Product NDC 70709-112
Description

1 BOTTLE, PLASTIC in 1 CARTON (70709-112-60) / 60 TABLET in 1 BOTTLE, PLASTIC

Marketing

Marketing Status
Marketed Since 2025-07-21
Brand harliku
Generic nitisinone
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2d883e57-720f-494e-be8f-db592ba0aa32", "openfda": {"nui": ["N0000175809", "N0000175808", "N0000185504", "N0000193955", "N0000190110", "N0000190111"], "upc": ["0370709112602"], "unii": ["K5BN214699"], "rxcui": ["1941474", "2719722"], "spl_set_id": ["7cf67e24-d46b-4376-bbd0-0b973c406d0d"], "pharm_class_epc": ["4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2E1 Inducers [MoA]", "Organic Anion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]"], "manufacturer_name": ["Cycle Pharmaceuticals Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70709-112-60)  / 60 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "70709-112-60", "marketing_start_date": "20250721"}], "brand_name": "HARLIKU", "product_id": "70709-112_2d883e57-720f-494e-be8f-db592ba0aa32", "dosage_form": "TABLET", "pharm_class": ["4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2E1 Inducers [MoA]", "Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]", "Organic Anion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]"], "product_ndc": "70709-112", "generic_name": "nitisinone", "labeler_name": "Cycle Pharmaceuticals Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HARLIKU", "active_ingredients": [{"name": "NITISINONE", "strength": "2 mg/1"}], "application_number": "NDA209449", "marketing_category": "NDA", "marketing_start_date": "20250721", "listing_expiration_date": "20261231"}