Lactulose
NDC Package 50436-3101-2

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Lactulose is a medication a laxative used to treat constipation. Marketed by Unit Dose Services, this product is identified by NDC 50436-3101 and is authorized under FDA application ANDA074076.

Identification & Billing

NDC Package Code
50436-3101-2
Package Description
946 mL in 1 BOTTLE
Product Code
50436-3101
11-Digit Billing Format
50436310102
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
946 ML

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
Unit Dose Services
FDA Application #
ANDA074076
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-03-1995
End Marketing Date
12-31-2017
Listing Expiration
12-31-2017
Exclude Flag
D
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 50436-3101-2 identifies a specific commercial package of 946 ml in 1 bottle of Lactulose, labeled by Unit Dose Services. This product is billed per "ML" milliliter and contains an estimated amount of 946 billable units per package. 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 Unit Dose Services on July 03, 1995. The current certification is valid through December 31, 2017.

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 Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436310102. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 946 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 (5-4-1)
50436-3101-2
11-Digit CMS (5-4-2)
50436-3101-02

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