Cimetidine Powder
NDC Package 72375-0010-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Cimetidine powders is cimetidine is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This formulation utilizes a powder delivery system. Marketed by Haleos Labs Limited, this product is identified by NDC 72375-0010.

Identification & Billing

NDC Package Code
72375-0010-1
Package Description
1 BAG in 1 DRUM / 25 kg in 1 BAG
Product Code
72375-0010
11-Digit Billing Format
72375001001

Clinical Specifications

Proprietary Name
Cimetidine
Non-Proprietary Name
Cimetidine
Substance Name
Cimetidine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
CIMETIDINE 1 kg/kg
Usage Information
Cimetidine 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 caused by too much stomach acid (e.g., Zollinger-Ellison syndrome, erosive esophagitis) or a backward flow of stomach acid into the esophagus (acid reflux disease/GERD). Decreasing extra stomach acid can help relieve symptoms such as stomach pain, heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus). Cimetidine belongs to a class of drugs commonly called H2 blockers. It works by reducing the amount of acid in your stomach. This medication is also available without a prescription. It is used to treat occasional heartburn caused by too much acid in the stomach (also called acid indigestion or sour stomach). It is also used to prevent heartburn and acid indigestion caused by certain foods and beverages. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

Regulatory & Marketing

Labeler Name
Haleos Labs Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-08-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 72375-0010-1 identifies a specific commercial package of 1 bag in 1 drum / 25 kg in 1 bag of Cimetidine (UNFINISHED drug), a bulk ingredient labeled by Haleos Labs Limited. This powder is formulated for use and contains cimetidine 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 Haleos Labs Limited on April 08, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cimetidine 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 caused by too much stomach acid (e.g., Zollinger-Ellison syndrome, erosive esophagitis) or a backward flow of stomach acid into the esophagus (acid reflux disease/GERD). Decreasing extra stomach acid can help relieve symptoms such as stomach pain, heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus). Cimetidine belongs to a class of drugs commonly called H2 blockers. It works by reducing the amount of acid in your stomach. This medication is also available without a prescription. It is used to treat occasional heartburn caused by too much acid in the stomach (also called acid indigestion or sour stomach). It is also used to prevent heartburn and acid indigestion caused by certain foods and beverages. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

How is this Haleos Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72375001001. 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)
72375-0010-1
11-Digit CMS (5-4-2)
72375-0010-01

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