What is NDC 57841-1150?

57841-1150 is the product NDC for Talicia, Omeprazole magnesium 10 mg/1 + 2 more ingredients capsule, delayed release, listed with the FDA by RedHill Biopharma Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Talicia (Omeprazole magnesium, amoxicillin and rifabutin).

What is the active ingredient?

Omeprazole magnesium, Amoxicillin, Rifabutin.

RedHill Biopharma Ltd, NDC labeler code 57841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Talicia?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Talicia NDC 57841-1150 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)57841-1150Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57841-1150Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
57841-1150-2	5784111500257841115002	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	5784111500457841115004	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 LtdNDC labeler code 57841
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 213004
Marketing start: Mar 9, 2020
Listing expires: Dec 31, 2027
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

N457841115002 followed by a unit qualifier and the quantity

Package 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

Current FDA label (SPL), effective Dec 23, 2025.

Indications (excerpt from the label)

TALICIA is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. ( 1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2) 1.1 Helicobacter pylori Infection TALICIA is indicated for the treatment of Helicobacter pylori infection in adults [see Clinical Studies (14 ) ] . 1.2 Usage To reduce the development of drug-resistant …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57841-1150

What is NDC 57841-1150?: 57841-1150 is the product NDC for Talicia, Omeprazole magnesium 10 mg/1 + 2 more ingredients capsule, delayed release, listed with the FDA by RedHill Biopharma Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Talicia (Omeprazole magnesium, amoxicillin and rifabutin).
What is the active ingredient?: Omeprazole magnesium, Amoxicillin, Rifabutin.
Who is the labeler?: RedHill Biopharma Ltd, NDC labeler code 57841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Talicia?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.