talicia

Generic: omeprazole magnesium, amoxicillin and rifabutin

Labeler: redhill biopharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name talicia
Generic Name omeprazole magnesium, amoxicillin and rifabutin
Labeler redhill biopharma ltd
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

amoxicillin 250 mg/1, omeprazole magnesium 10 mg/1, rifabutin 12.5 mg/1

Manufacturer
RedHill Biopharma Ltd

Identifiers & Regulatory

Product NDC 57841-1150
Product ID 57841-1150_0649301c-fc4e-42a4-a62d-9a023a3f9f98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213004
Listing Expiration 2026-12-31
Marketing Start 2020-03-09

Pharmacologic Class

Established (EPC)
rifamycin antimycobacterial [epc]
Chemical Structure
rifamycins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 578411150
Hyphenated Format 57841-1150

Supplemental Identifiers

RxCUI
2262026 2262032
UPC
0357841115012
UNII
804826J2HU 426QFE7XLK 1W306TDA6S
NUI
N0000175501 M0019113

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name talicia (source: ndc)
Generic Name omeprazole magnesium, amoxicillin and rifabutin (source: ndc)
Application Number NDA213004 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 10 mg/1
  • 12.5 mg/1
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)
  • 2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)
source: ndc

Packages (2)

57841-1150-2 2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1) 57841-1150-4 2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)

Ingredients (3)

amoxicillin (250 mg/1) omeprazole magnesium (10 mg/1) rifabutin (12.5 mg/1)

Linked Drug Pages (1)

Talicia ndc-match (0.9)

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"}