Lactulose
NDC Package 62559-5501-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

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 Anip Acquisition Company, this product is identified by NDC 62559-5501 and is authorized under FDA application ANDA078430.

Identification & Billing

NDC Package Code
62559-5501-3
Package Description
946 mL in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
62559550103
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
Anip Acquisition Company
FDA Application #
ANDA078430
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-20-2010
End Marketing Date
07-21-2018
Listing Expiration
07-21-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62559-5501). Click a package code to view its specific billing and regulatory data.

473 mL in 1 BOTTLE, PLASTIC
237 mL in 1 BOTTLE, PLASTIC

* 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 62559-5501-3 identifies a specific commercial package of 946 ml in 1 bottle, plastic of Lactulose, labeled by Anip Acquisition Company. 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 Anip Acquisition Company on July 20, 2010. The current certification is valid through July 21, 2018.

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 Anip Acquisition Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62559550103. 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)
62559-5501-3
11-Digit CMS (5-4-2)
62559-5501-03

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