Lactulose Powder
NDC Package 18124-003-00

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.

Lactulose powders is a medication a laxative used to treat constipation. This formulation utilizes a powder delivery system. Marketed by Fresenius Kabi Aut Gmbh, this product is identified by NDC 18124-003.

Identification & Billing

NDC Package Code
18124-003-00
Package Description
50 kg in 1 DRUM
Product Code
18124-003
11-Digit Billing Format
18124000300

Clinical Specifications

Proprietary Name
Lactulose
Non-Proprietary Name
Lactulose
Substance Name
Lactulose
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)
LACTULOSE 50 kg/50kg
Usage Information
This medication is a laxative used to treat constipation. It may help to increase the number of bowel movements per day and the number of days you have a bowel movement. Lactulose is a colonic acidifier that works by increasing stool water content and softening the stool. It is a man-made sugar solution.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Aut Gmbh
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-01-2017
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 18124-003-00 identifies a specific commercial package of 50 kg in 1 drum of Lactulose (UNFINISHED drug), a bulk ingredient labeled by Fresenius Kabi Aut Gmbh. This powder is formulated for use and contains lactulose 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 Fresenius Kabi Aut Gmbh on September 01, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a laxative used to treat constipation. It may help to increase the number of bowel movements per day and the number of days you have a bowel movement. Lactulose is a colonic acidifier that works by increasing stool water content and softening the stool. It is a man-made sugar solution.

How is this Fresenius Kabi Aut Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 18124000300. 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)
18124-003-00
11-Digit CMS (5-4-2)
18124-0003-00

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