Lactulose Solution
NDC Package 81033-241-51

11-digit billing NDC: 81033024151 · Billing unit: ML · 3000 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Lactulose Solution (lactulose solution usp, 10 g/15 ml) solution is for the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. This formulation utilizes a solution delivery system. Marketed by Kesin Pharma Corporation, this product is identified by NDC 81033-241 and is authorized under FDA application ANDA076645.

Identification & Billing

NDC Package Code
81033-241-51
Package Description
100 CUP, UNIT-DOSE in 1 CASE / 30 mL in 1 CUP, UNIT-DOSE (81033-241-30)
Product Code
81033-241
11-Digit Billing Format
81033024151
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
3000 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lactulose Solution
Non-Proprietary Name
Lactulose Solution Usp, 10 G/15 Ml
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.
  • Oral - Administration to or by way of the mouth.
  • Rectal - Administration to the rectum.
Active Ingredient(s)
Pharmacologic Class
Usage Information
For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia level by 25 to 50%; this is generally paralleled by an improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution has been given for over 2 years in controlled studies.

Regulatory & Marketing

Labeler Name
Kesin Pharma Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA076645
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-16-2021
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81033-241). Click a package code to view its specific billing and regulatory data.

81033-241-32
946 mL in 1 BOTTLE, PLASTIC
81033-241-50
100 CUP, UNIT-DOSE in 1 CASE / 15 mL in 1 CUP, UNIT-DOSE (81033-241-15)

* 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 81033-241-51 identifies a specific commercial package of 100 cup, unit-dose in 1 case / 30 ml in 1 cup, unit-dose (81033-241-30) of Lactulose Solution, a human prescription drug labeled by Kesin Pharma Corporation. 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 Kesin Pharma Corporation on April 16, 2021. The current certification is valid through December 31, 2027.

How is this Kesin Pharma Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033024151. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 3000 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)
81033-241-51
11-Digit CMS (5-4-2)
81033-0241-51

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