Prescription drug · NDA
Talicia NDC 57841-1150
omeprazole magnesium, amoxicillin and rifabutin · Omeprazole magnesium 10 mg/1 + 2 more ingredients · Capsule, Delayed release · Oral · RedHill Biopharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57841-1150-2 | 57841115002 | 2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)Marketed from Mar 9, 2020 | |
| 57841-1150-4 | 57841115004 | 2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)Marketed from Sep 24, 2021 · Sample package |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Talicia
- Generic name (nonproprietary)
- omeprazole magnesium, amoxicillin and rifabutin
- Active ingredients
- Omeprazole magnesium — 10 mg/1Amoxicillin — 250 mg/1Rifabutin — 12.5 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- RedHill Biopharma Ltd
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213004
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Penicillins (Chemical structure)Proton Pump Inhibitors (Mechanism)Rifamycins (Chemical structure)
- Identifiers
- Product ID 57841-1150_0649301c-fc4e-42a4-a62d-9a023a3f9f98SPL ID 0649301c-fc4e-42a4-a62d-9a023a3f9f98SPL set ID 68c4e9dc-dbcf-4151-b6f7-5e4b9922b76fRxCUI 2262026, 2262032UNII 426QFE7XLK, 804826J2HU, 1W306TDA6SUPC 0357841115012
- Pharmacologic class
- Penicillin-class Antibacterial; Proton Pump Inhibitor; Rifamycin Antimycobacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N457841115002followed by a unit qualifier and the quantityPackage 57841-1150-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.