Talicia
- Product NDC
- 57841-1150
- 11-digit product format
- 578411150
- Labeler code
- 57841
- Product ID
- 57841-1150_0649301c-fc4e-42a4-a62d-9a023a3f9f98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole magnesium, amoxicillin and rifabutin
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- RedHill Biopharma Ltd
- Application
- NDA213004
- Marketing category
- NDA
- Marketing start
- 2020-03-09
- Substance
- AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
- Active strength
- 250; 10; 12.5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Penicillin-class Antibacterial [EPC], Penicillins [CS], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA], Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Talicia
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 250 mg/1 |
| OMEPRAZOLE MAGNESIUM | 10 mg/1 |
| RIFABUTIN | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, 426QFE7XLK, 1W306TDA6S |
| Rxcui | 2262026, 2262032 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57841-1150-1 | Talicia | 84 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 84 | | 10 |
| 57841-1150-2 | Talicia | 2 in 1 CARTON | CAPSULE, DELAYED RELEASE | 2 | | 10 |
| 57841-1150-3 | Talicia | 84 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 84 | | 10 |
| 57841-1150-4 | Talicia | 2 in 1 CARTON | CAPSULE, DELAYED RELEASE | 2 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57841-1150 | TALICIA (OMEPRAZOLE MAGNESIUM, AMOXICILLIN AND RIFABUTIN) CAPSULE, DELAYED RELEASE [REDHILL BIOPHARMA LTD] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240503_68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57841-1150-1 | 57841115001 | 84 in 1 BOTTLE | | | | | | Historical |
| 57841-1150-2 | 57841115002 | 2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1) | 2 bottle | 2020-03-09 | 0000-00-00 | No | No | Current |
| 57841-1150-3 | 57841115003 | 84 in 1 BOTTLE | | | | | | Historical |
| 57841-1150-4 | 57841115004 | 2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3) | 2 bottle | 2021-09-24 | 0000-00-00 | Yes | No | Current |