Zantac
NDC Package 52565-101-25

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Zantac is ranitidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. Marketed by Teligent Pharma, Inc., this product is identified by NDC 52565-101 and is authorized under FDA application NDA019090.

Identification & Billing

NDC Package Code
52565-101-25
Package Description
25 VIAL in 1 CARTON / 2 mL in 1 VIAL
Product Code
52565-101
11-Digit Billing Format
52565010125
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zantac
Dosage Form
-
Usage Information
Ranitidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Ranitidine belongs to a class of drugs known as H2 blockers. This form of ranitidine is given by injection and is used for short-term treatment of these conditions when you cannot take this medication by mouth. Your doctor should switch you to taking this medication by mouth when possible. This drug has been withdrawn from the US market due to problems with safety. A possible cancer-causing impurity has been found in some ranitidine products.

Regulatory & Marketing

Labeler Name
Teligent Pharma, Inc.
FDA Application #
NDA019090
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-23-2017
Listing Expiration
12-31-2021
Exclude Flag
I
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 52565-101-25 identifies a specific commercial package of 25 vial in 1 carton / 2 ml in 1 vial of Zantac, labeled by Teligent Pharma, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Teligent Pharma, Inc. on August 23, 2017. The current certification is valid through December 31, 2021.

What are the primary indications for this medication?

Ranitidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Ranitidine belongs to a class of drugs known as H2 blockers. This form of ranitidine is given by injection and is used for short-term treatment of these conditions when you cannot take this medication by mouth. Your doctor should switch you to taking this medication by mouth when possible. This drug has been withdrawn from the US market due to problems with safety. A possible cancer-causing impurity has been found in some ranitidine products.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52565010125. 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)
52565-101-25
11-Digit CMS (5-4-2)
52565-0101-25

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