Polyethylene Glycol 3350
NDC Package 0722-6921-01

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 inactivated by the FDA.

Polyethylene Glycol 3350 is a medication used to treat occasional constipation. Marketed by Nexgen Pharma, Inc., this product is identified by NDC 0722-6921 and is authorized under FDA application ANDA077706.

Identification & Billing

NDC Package Code
0722-6921-01
Package Description
255 POWDER, FOR SOLUTION in 1 BOTTLE, PLASTIC
Product Code
0722-6921
11-Digit Billing Format
00722692101
RxNorm Crosswalk
  • RxCUI: 876193 - polyethylene glycol 3350 17 GM Powder for Oral Solution
  • RxCUI: 876193 - polyethylene glycol 3350 17000 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Polyethylene Glycol 3350
Dosage Form
-
Usage Information
This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative. This medication is also available without a prescription. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

Regulatory & Marketing

Labeler Name
Nexgen Pharma, Inc.
FDA Application #
ANDA077706
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-27-2006
Listing Expiration
12-31-2019
Exclude Flag
I
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 0722-6921-01 identifies a specific commercial package of 255 powder, for solution in 1 bottle, plastic of Polyethylene Glycol 3350, labeled by Nexgen Pharma, 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 Nexgen Pharma, Inc. on September 27, 2006. The current certification is valid through December 31, 2019.

What are the primary indications for this medication?

This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative. This medication is also available without a prescription. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)

How is this Nexgen Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00722692101. 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 (4-4-2)
0722-6921-01
11-Digit CMS (5-4-2)
00722-6921-01

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