Package 0078-1189-20

Brand: fabhalta

Generic: iptacopan
NDC Package

Package Facts

Identity

Package NDC 0078-1189-20
Digits Only 0078118920
Product NDC 0078-1189
Product ID 0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a
Description

60 CAPSULE in 1 BOTTLE (0078-1189-20)

Marketing

Marketing Status
Marketed Since 2023-12-05
Brand fabhalta
Generic iptacopan
Sample Package No

Linked Drug Pages (1)

FABHALTA ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f0bead0e-4eed-4db9-a076-1d974eba6b4a", "openfda": {"unii": ["XW5CK7C6YH"], "rxcui": ["2671074", "2671080"], "spl_set_id": ["a76b5845-6e21-4d3b-ad07-cd8df1b60bee"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (0078-1189-20)", "package_ndc": "0078-1189-20", "marketing_start_date": "20231205"}], "brand_name": "FABHALTA", "product_id": "0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a", "dosage_form": "CAPSULE", "pharm_class": ["Complement Factor B Inhibitor [EPC]", "Complement Factor B Inhibitors [MoA]"], "product_ndc": "0078-1189", "generic_name": "iptacopan", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FABHALTA", "active_ingredients": [{"name": "IPTACOPAN HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "NDA218276", "marketing_category": "NDA", "marketing_start_date": "20231205", "listing_expiration_date": "20261231"}