Nulytely With Flavor Packs
NDC Package 52268-400-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Nulytely With Flavor Packs is pEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy or barium enema X-rays. Marketed by Braintree Laboratories, Inc., this product is identified by NDC 52268-400 and is authorized under FDA application NDA019797.

Identification & Billing

NDC Package Code
52268-400-01
Package Description
1 KIT in 1 KIT * 4 L in 1 BOTTLE * .0002 L in 1 PACKET * .0002 L in 1 PACKET * .0002 L in 1 PACKET * .0002 L in 1 PACKET
Product Code
52268-400
11-Digit Billing Format
52268040001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Nulytely With Flavor Packs
Dosage Form
-
Usage Information
PEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy or barium enema X-rays. It is a laxative that works by drawing large amounts of water into the colon. This effect results in watery bowel movements. Clearing stool from the intestines helps your doctor to better examine the intestines during your procedure.

Regulatory & Marketing

Labeler Name
Braintree Laboratories, Inc.
FDA Application #
NDA019797
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-17-2007
End Marketing Date
01-31-2023
Listing Expiration
01-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52268-400-01 identifies a specific commercial package of 1 kit in 1 kit * 4 l in 1 bottle * .0002 l in 1 packet * .0002 l in 1 packet * .0002 l in 1 packet * .0002 l in 1 packet of Nulytely With Flavor Packs, labeled by Braintree Laboratories, Inc.. 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 Braintree Laboratories, Inc. on April 17, 2007. The current certification is valid through January 31, 2023.

What are the primary indications for this medication?

PEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy or barium enema X-rays. It is a laxative that works by drawing large amounts of water into the colon. This effect results in watery bowel movements. Clearing stool from the intestines helps your doctor to better examine the intestines during your procedure.

How is this Braintree Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52268040001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
52268-400-01
11-Digit CMS (5-4-2)
52268-0400-01

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