Lansoprazole, Amoxicillin, Clarithromycin Kit
NDC Package 57237-001-14

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

Package Information

Lansoprazole, Amoxicillin, Clarithromycin kits is h. This formulation utilizes a kit delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-001 and is authorized under FDA application ANDA206006.

Identification & Billing

NDC Package Code
57237-001-14
Package Description
14 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (57237-001-01)
Product Code
57237-001
11-Digit Billing Format
57237000114
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
14 EA
RxNorm Crosswalk
  • RxCUI: 197517 - clarithromycin 500 MG Oral Tablet
  • RxCUI: 308191 - amoxicillin 500 MG Oral Capsule
  • RxCUI: 308191 - amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule
  • RxCUI: 311277 - lansoprazole 30 MG Delayed Release Oral Capsule
  • RxCUI: 757968 - {4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (lansoprazole 30 MG Delayed Release Oral Capsule) } Pack

Clinical Specifications

Proprietary Name
Lansoprazole, Amoxicillin, Clarithromycin
Non-Proprietary Name
Lansoprazole, Amoxicillin, Clarithromycin
Dosage Form
Kit - A packaged collection of related material.
Usage Information
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceThe components in lansoprazole delayed-release capsules USP, amoxicillin capsules USP, and clarithromycin tablets USP are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence (see CLINICAL STUDIES  and DOSAGE AND ADMINISTRATION).To reduce the development of drug-resistant bacteria and maintain the effectiveness of lansoprazole delayed-release capsules USP, amoxicillin capsules USP, and clarithromycin tablets USP and other antibacterial drugs, lansoprazole delayed-release capsules USP, amoxicillin capsules USP, and clarithromycin tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206006
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-14-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57237-001-14 identifies a specific commercial package of 14 blister pack in 1 carton / 1 kit in 1 blister pack (57237-001-01) of Lansoprazole, Amoxicillin, Clarithromycin, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This kit is formulated for use and contains 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 Rising Pharma Holdings, Inc. on October 14, 2016. The current certification is valid through December 31, 2026.

How is this Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237000114. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 14 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 (5-3-2)
57237-001-14
11-Digit CMS (5-4-2)
57237-0001-14

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