Talicia Capsule, Delayed Release
NDC Package 57841-1150-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Talicia (omeprazole magnesium, amoxicillin and rifabutin) capsules is tALICIA is indicated for the treatment of Helicobacter pylori infection in adults [see Clinical Studies (14)]. This formulation utilizes a capsule, delayed release delivery system. Marketed by Redhill Biopharma Ltd, this product is identified by NDC 57841-1150 and is authorized under FDA application NDA213004.

Identification & Billing

NDC Package Code
57841-1150-2
Package Description
2 BOTTLE in 1 CARTON / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1)
Product Code
57841-1150
11-Digit Billing Format
57841115002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk
  • RxCUI: 2262026 - amoxicillin 250 MG / omeprazole 10 MG / rifabutin 12.5 MG Delayed Release Oral Capsule
  • RxCUI: 2262032 - TALICIA 250 MG / 10 MG / 12.5 MG Delayed Release Oral Capsule
  • RxCUI: 2262032 - amoxicillin 250 MG / omeprazole 10 MG / rifabutin 12.5 MG Delayed Release Oral Capsule [Talicia]
  • RxCUI: 2262032 - Talicia 250 MG / 10 MG / 12.5 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Talicia
Non-Proprietary Name
Omeprazole Magnesium, Amoxicillin And Rifabutin
Substance Name
Amoxicillin; Omeprazole Magnesium; Rifabutin
Dosage Form
Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
TALICIA is indicated for the treatment of Helicobacter pylori infection in adults [see Clinical Studies (14)].  

Regulatory & Marketing

Labeler Name
Redhill Biopharma Ltd
Product Type
Human Prescription Drug
FDA Application #
NDA213004
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-09-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57841-1150). Click a package code to view its specific billing and regulatory data.

57841-1150-4
2 BOTTLE in 1 CARTON / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57841-1150-2 identifies a specific commercial package of 2 bottle in 1 carton / 84 capsule, delayed release in 1 bottle (57841-1150-1) of Talicia, a human prescription drug labeled by Redhill Biopharma Ltd. This capsule, delayed release is formulated for oral use and contains amoxicillin; omeprazole magnesium; rifabutin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Redhill Biopharma Ltd on March 09, 2020. The current certification is valid through December 31, 2026.

How is this Redhill Biopharma Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57841115002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
57841-1150-2
11-Digit CMS (5-4-2)
57841-1150-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.