Lactulose
NDC Package 17856-1378-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Lactulose is a medication a laxative used to treat constipation. Marketed by Atlantic Biologicals Corps, this product is identified by NDC 17856-1378 and is authorized under FDA application ANDA075993.

Identification & Billing

NDC Package Code
17856-1378-2
Package Description
15 mL in 1 CUP
Product Code
17856-1378
11-Digit Billing Format
17856137802
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lactulose
Dosage Form
-
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
Atlantic Biologicals Corps
FDA Application #
ANDA075993
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-2001
Listing Expiration
12-31-2022
Exclude Flag
I
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 (17856-1378). Click a package code to view its specific billing and regulatory data.

17856-1378-1
30 mL in 1 CUP

* 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 17856-1378-2 identifies a specific commercial package of 15 ml in 1 cup of Lactulose, labeled by Atlantic Biologicals Corps. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Atlantic Biologicals Corps on July 26, 2001. The current certification is valid through December 31, 2022.

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 Atlantic Biologicals Corps product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856137802. 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)
17856-1378-2
11-Digit CMS (5-4-2)
17856-1378-02

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