Nizatidine
NDC Package 54868-4643-1

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Nizatidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4643 and is authorized under FDA application ANDA076178.

Identification & Billing

NDC Package Code
54868-4643-1
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
54868-4643
11-Digit Billing Format
54868464301

Clinical Specifications

Proprietary Name
Nizatidine
Dosage Form
-
Usage Information
Nizatidine 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). 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. Nizatidine belongs to a class of drugs known as H2 blockers.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA076178
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-25-2004
End Marketing Date
12-31-2006
Listing Expiration
12-31-2006
Exclude Flag
D
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 (54868-4643). Click a package code to view its specific billing and regulatory data.

54868-4643-0
60 CAPSULE in 1 BOTTLE

* 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 54868-4643-1 identifies a specific commercial package of 100 capsule in 1 bottle of Nizatidine, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on February 25, 2004. The current certification is valid through December 31, 2006.

What are the primary indications for this medication?

Nizatidine 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). 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. Nizatidine belongs to a class of drugs known as H2 blockers.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868464301. 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)
54868-4643-1
11-Digit CMS (5-4-2)
54868-4643-01

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