Nizatidine Solution
NDC Package 60846-301-15

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

Package Information

Nizatidine solution 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 solution delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 60846-301 and is authorized under FDA application ANDA090576.

Identification & Billing

NDC Package Code
60846-301-15
Package Description
480 mL in 1 BOTTLE
Product Code
60846-301
11-Digit Billing Format
60846030115
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
480 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nizatidine
Non-Proprietary Name
Nizatidine
Substance Name
Nizatidine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NIZATIDINE 15 mg/mL
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
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090576
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-12-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60846-301-15 identifies a specific commercial package of 480 ml in 1 bottle of Nizatidine, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This solution 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 Amneal Pharmaceuticals Llc on August 12, 2016. 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 Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60846030115. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 480 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)
60846-301-15
11-Digit CMS (5-4-2)
60846-0301-15

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