Constulose Solution
NDC Package 45963-439-65

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

Constulose (lactulose) solution is a medication a laxative used to treat constipation. This formulation utilizes a solution delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 45963-439 and is authorized under FDA application ANDA090503.

Identification & Billing

NDC Package Code
45963-439-65
Package Description
946 mL in 1 BOTTLE
Product Code
45963-439
11-Digit Billing Format
45963043965
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
946 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Constulose
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.
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
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090503
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-28-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45963-439). Click a package code to view its specific billing and regulatory data.

45963-439-63
237 mL in 1 BOTTLE

* 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 45963-439-65 identifies a specific commercial package of 946 ml in 1 bottle of Constulose, a human prescription drug labeled by Actavis Pharma, Inc.. This 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 Actavis Pharma, Inc. on February 28, 2011. 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 Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45963043965. 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 (5-3-2)
45963-439-65
11-Digit CMS (5-4-2)
45963-0439-65

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