Nizatidine Capsule
NDC Package 55111-310-05

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

Nizatidine capsules is nizatidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This formulation utilizes a capsule delivery system. Marketed by Dr Reddy's Laboratories Limited, this product is identified by NDC 55111-310 and is authorized under FDA application ANDA077314.

Identification & Billing

NDC Package Code
55111-310-05
Package Description
500 CAPSULE in 1 BOTTLE
Product Code
55111-310
11-Digit Billing Format
55111031005
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nizatidine
Non-Proprietary Name
Nizatidine
Substance Name
Nizatidine
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NIZATIDINE 150 mg/1
Pharmacologic Class
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
Dr Reddy's Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA077314
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2005
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55111-310). Click a package code to view its specific billing and regulatory data.

55111-310-01
100 CAPSULE in 1 BOTTLE
55111-310-30
30 CAPSULE in 1 BOTTLE
55111-310-60
60 CAPSULE in 1 BOTTLE
55111-310-78
10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (55111-310-79)

* 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 55111-310-05 identifies a specific commercial package of 500 capsule in 1 bottle of Nizatidine, a human prescription drug labeled by Dr Reddy's Laboratories Limited. This capsule is formulated for oral use and contains nizatidine 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 Dr Reddy's Laboratories Limited on September 15, 2005. The current certification is valid through December 31, 2026.

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 Dr Reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111031005. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
55111-310-05
11-Digit CMS (5-4-2)
55111-0310-05

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