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NDC 57841-1150-04 Talicia 250; 10; 12.5 mg/1; mg/1; mg/1 Details
Talicia 250; 10; 12.5 mg/1; mg/1; mg/1
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 AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN.
MedlinePlus Drug Summary
Amoxicillin is used to treat certain infections caused by bacteria, such as pneumonia; bronchitis (infection of the airway tubes leading to the lungs); and infections of the ears, nose, throat, urinary tract, and skin. It is also used in combination with other medications to eliminate H. pylori, a bacteria that causes ulcers. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 57841-1150-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amoxicillin
Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 57841-1150-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Omeprazole
Rifabutin helps to prevent or slow the spread of Mycobacterium avium complex disease (MAC; a bacterial infection that may cause serious symptoms) in patients with human immunodeficiency virus (HIV) infection. It is also used in combination with other medications to eliminate H. pylori, a bacteria that causes ulcers. Rifabutin is in a class of medications called antimycobacterials. It works by killing the bacteria that cause infection. Antibiotics such as rifabutin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 57841-1150-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Rifabutin
Product Information
| NDC | 57841-1150 |
|---|---|
| Product ID | 57841-1150_23124460-5e8c-46a8-b2a7-9ee4f94b58ca |
| Associated GPIs | 49993003406520 |
| GCN Sequence Number | 080455 |
| GCN Sequence Number Description | omeprazole/amoxicill/rifabutin CAP IR DR 10MG-250MG ORAL |
| HIC3 | D4F |
| HIC3 Description | ANTI-ULCER-H.PYLORI AGENTS |
| GCN | 47303 |
| HICL Sequence Number | 046200 |
| HICL Sequence Number Description | OMEPRAZOLE MAGNESIUM/AMOXICILLIN TRIHYDRATE/RIFABUTIN |
| Brand/Generic | Brand |
| Proprietary Name | Talicia |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | omeprazole magnesium, amoxicillin and rifabutin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 250; 10; 12.5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN |
| Labeler Name | RedHill Biopharma Ltd |
| Pharmaceutical 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] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213004 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 57841-1150-04 (57841115004)
| NDC Package Code | 57841-1150-4 |
|---|---|
| Billing NDC | 57841115004 |
| Package | 2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3) |
| Marketing Start Date | 2021-09-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |