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

Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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

Proprietary Name:

Lansoprazole, Amoxicillin, Clarithromycin

Non-Proprietary Name:

Lansoprazole, Amoxicillin, Clarithromycin

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.

11-Digit NDC Billing Format:

57237000114

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

14 EA

NDC to 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

Product Type:

Human Prescription Drug

Labeler Name:

Rising Pharma Holdings, Inc.

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

ANDA206006

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

10-14-2016

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

57237 - Rising Pharma Holdings, Inc.
- 57237-001 - Lansoprazole, Amoxicillin, Clarithromycin
  - 57237-001-14 - 14 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (57237-001-01)

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 disclaimer below.

Frequently Asked Questions

What is NDC 57237-001-14?

The NDC Packaged Code 57237-001-14 is assigned to a 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.. The product's dosage form is kit and is administered via form.

Is NDC 57237-001 included in the NDC Directory?

Yes, Lansoprazole, Amoxicillin, Clarithromycin with product code 57237-001 is active and included in the NDC Directory. The product was first marketed by Rising Pharma Holdings, Inc. on October 14, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 57237-001-14?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 14.

What is the 11-digit format for NDC 57237-001-14?

The 11-digit format is 57237000114. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	57237-001-14	5-4-2	57237-0001-14

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