Generlac Solution
NDC Package 62135-892-47

11-digit billing NDC: 62135089247 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Generlac (lactulose) solution is 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 levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. This formulation utilizes a solution delivery system. Marketed by Chartwell Rx, Llc, this product is identified by NDC 62135-892 and is authorized under FDA application ANDA074603.

Identification & Billing

NDC Package Code
62135-892-47
Package Description
473 mL in 1 BOTTLE
Product Code
62135-892
11-Digit Billing Format
62135089247
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
Generlac
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
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 levels 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
Chartwell Rx, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA074603
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-1996
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 (62135-892). Click a package code to view its specific billing and regulatory data.

62135-892-94
946 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 62135-892-47 identifies a specific commercial package of 473 ml in 1 bottle of Generlac, a human prescription drug labeled by Chartwell Rx, Llc. 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 Chartwell Rx, Llc on October 31, 1996. The current certification is valid through December 31, 2027.

How is this Chartwell Rx, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135089247. 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)
62135-892-47
11-Digit CMS (5-4-2)
62135-0892-47

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