Package 57841-1150-2

Brand: talicia

Generic: omeprazole magnesium, amoxicillin and rifabutin
NDC Package

Package Facts

Identity

Package NDC 57841-1150-2
Digits Only 5784111502
Product NDC 57841-1150
Description

2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)

Marketing

Marketing Status
Marketed Since 2020-03-09
Brand talicia
Generic omeprazole magnesium, amoxicillin and rifabutin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "0649301c-fc4e-42a4-a62d-9a023a3f9f98", "openfda": {"nui": ["N0000175501", "M0019113"], "upc": ["0357841115012"], "unii": ["804826J2HU", "426QFE7XLK", "1W306TDA6S"], "rxcui": ["2262026", "2262032"], "spl_set_id": ["68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f"], "pharm_class_cs": ["Rifamycins [CS]"], "pharm_class_epc": ["Rifamycin Antimycobacterial [EPC]"], "manufacturer_name": ["RedHill Biopharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (57841-1150-2)  / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)", "package_ndc": "57841-1150-2", "marketing_start_date": "20200309"}, {"sample": true, "description": "2 BOTTLE in 1 CARTON (57841-1150-4)  / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)", "package_ndc": "57841-1150-4", "marketing_start_date": "20210924"}], "brand_name": "Talicia", "product_id": "57841-1150_0649301c-fc4e-42a4-a62d-9a023a3f9f98", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]", "Rifamycin Antimycobacterial [EPC]", "Rifamycins [CS]"], "product_ndc": "57841-1150", "generic_name": "omeprazole magnesium, amoxicillin and rifabutin", "labeler_name": "RedHill Biopharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Talicia", "active_ingredients": [{"name": "AMOXICILLIN", "strength": "250 mg/1"}, {"name": "OMEPRAZOLE MAGNESIUM", "strength": "10 mg/1"}, {"name": "RIFABUTIN", "strength": "12.5 mg/1"}], "application_number": "NDA213004", "marketing_category": "NDA", "marketing_start_date": "20200309", "listing_expiration_date": "20261231"}