Lactulose Powder, For Solution
NDC Package 85592-829-30

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

Package Information

Lactulose powders is a medication a laxative used to treat constipation. This formulation utilizes a powder, for solution delivery system. Marketed by Cumberland Assured Products Inc., this product is identified by NDC 85592-829 and is authorized under FDA application ANDA074712.

Identification & Billing

NDC Package Code
85592-829-30
Package Description
30 POUCH in 1 CARTON / 20 g in 1 POUCH (85592-829-01)
Product Code
85592-829
11-Digit Billing Format
85592082930
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lactulose Crystalline
Non-Proprietary Name
Lactulose
Substance Name
Lactulose
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LACTULOSE 20 g/20g
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
Cumberland Assured Products Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA074712
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2025
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 85592-829-30 identifies a specific commercial package of 30 pouch in 1 carton / 20 g in 1 pouch (85592-829-01) of Lactulose Crystalline, a human prescription drug labeled by Cumberland Assured Products Inc.. This powder, for solution is formulated for oral 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 Cumberland Assured Products Inc. on September 01, 2025. 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 Cumberland Assured Products Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85592082930. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
85592-829-30
11-Digit CMS (5-4-2)
85592-0829-30

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