NDC 57841-1150

Talicia

Omeprazole Magnesium, Amoxicillin And Rifabutin

Talicia is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Redhill Biopharma Ltd. The primary component is Omeprazole Magnesium; Amoxicillin; Rifabutin.

Product ID57841-1150_0f01718c-c8cb-4894-8463-6b738a34b248
NDC57841-1150
Product TypeHuman Prescription Drug
Proprietary NameTalicia
Generic NameOmeprazole Magnesium, Amoxicillin And Rifabutin
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-03-09
Marketing CategoryNDA / NDA
Application NumberNDA213004
Labeler NameRedHill Biopharma Ltd
Substance NameOMEPRAZOLE MAGNESIUM; AMOXICILLIN; RIFABUTIN
Active Ingredient Strength10 mg/1; mg/1; mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [CS],Rifamycin Antimycobacterial [EPC],Rifamycins [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 57841-1150-2

2 BOTTLE in 1 CARTON (57841-1150-2) > 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)
Marketing Start Date2020-03-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57841-1150-1 [57841115001]

Talicia CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA213004
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-09

NDC 57841-1150-2 [57841115002]

Talicia CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA213004
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-09

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE MAGNESIUM10 mg/1

OpenFDA Data

SPL SET ID:68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2262032
  • 2262026
    • UPC Code
  • 0357841115012

    • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Penicillin-class Antibacterial [EPC]
    • Penicillins [CS]
    • Rifamycin Antimycobacterial [EPC]
    • Rifamycins [CS]

    Trademark Results [Talicia]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TALICIA
    TALICIA
    88675178 not registered Live/Pending
    RedHill Biopharma, Ltd.
    2019-10-31
    TALICIA
    TALICIA
    88391531 not registered Live/Pending
    RedHill Biopharma, Ltd.
    2019-04-18
    TALICIA
    TALICIA
    87235778 5392689 Live/Registered
    RedHill Biopharma, Ltd.
    2016-11-14
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.