Enulose Solution
NDC Package 45963-438-64

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

Package Information

Enulose (lactulose) solution is a medication used by mouth or rectally to treat or prevent complications of liver disease (hepatic encephalopathy). This formulation utilizes a solution delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 45963-438 and is authorized under FDA application ANDA090502.

Identification & Billing

NDC Package Code
45963-438-64
Package Description
473 mL in 1 BOTTLE
Product Code
45963-438
11-Digit Billing Format
45963043864
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Enulose
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.
  • Rectal - Administration to the rectum.
Active Ingredient(s)
LACTULOSE 10 g/15mL
Pharmacologic Class
Usage Information
This drug is used by mouth or rectally to treat or prevent complications of liver disease (hepatic encephalopathy). It does not cure the problem, but may help to improve mental status. Lactulose is a colonic acidifier that works by decreasing the amount of ammonia in the blood. It is a man-made sugar solution.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA090502
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45963-438-64 identifies a specific commercial package of 473 ml in 1 bottle of Enulose, a human prescription drug labeled by Actavis Pharma, Inc.. 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 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 drug is used by mouth or rectally to treat or prevent complications of liver disease (hepatic encephalopathy). It does not cure the problem, but may help to improve mental status. Lactulose is a colonic acidifier that works by decreasing the amount of ammonia in the blood. 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: 45963043864. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
45963-438-64
11-Digit CMS (5-4-2)
45963-0438-64

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