Lactulose Solution
NDC Package 18124-002-16

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

Package Information

Lactulose solution is a medication a laxative used to treat constipation. This formulation utilizes a solution delivery system. Marketed by Fresenius Kabi Austria Gmbh, this product is identified by NDC 18124-002 and is authorized under FDA application ANDA090502.

Identification & Billing

NDC Package Code
18124-002-16
Package Description
473 mL in 1 BOTTLE
Product Code
18124-002
11-Digit Billing Format
18124000216
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lactulose
Non-Proprietary Name
Lactulose
Substance Name
Lactulose
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.
  • Rectal - Administration to the rectum.
Active Ingredient(s)
LACTULOSE 10 g/15mL
Pharmacologic Class
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 Austria Gmbh
Product Type
Human Prescription Drug
FDA Application #
ANDA090502
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-10-2012
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 18124-002-16 identifies a specific commercial package of 473 ml in 1 bottle of Lactulose, a human prescription drug labeled by Fresenius Kabi Austria Gmbh. This solution is formulated for oral; rectal 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 Austria Gmbh on December 10, 2012. 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 Austria Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 18124000216. 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)
18124-002-16
11-Digit CMS (5-4-2)
18124-0002-16

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