Nizatidine
NDC Package 55567-110-13

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 Genpharm Ulc, this product is identified by NDC 55567-110 and is authorized under FDA application ANDA075934.

Identification & Billing

NDC Package Code
55567-110-13
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
55567-110
11-Digit Billing Format
55567011013

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
Genpharm Ulc
FDA Application #
ANDA075934
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2015
End Marketing Date
11-30-2015
Listing Expiration
11-30-2015
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 (55567-110). Click a package code to view its specific billing and regulatory data.

55567-110-15
50 CAPSULE in 1 BOTTLE
55567-110-25
500 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 55567-110-13 identifies a specific commercial package of 30 capsule in 1 bottle of Nizatidine, labeled by Genpharm Ulc. 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 Genpharm Ulc on November 01, 2015. The current certification is valid through November 30, 2015.

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 Genpharm Ulc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55567011013. 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)
55567-110-13
11-Digit CMS (5-4-2)
55567-0110-13

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