Polyethylene Glycol 3350 Powder, For Solution
NDC Package 68001-607-69

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

Package Information

Polyethylene Glycol 3350 powders is a medication used to treat occasional constipation. This formulation utilizes a powder, for solution delivery system. Marketed by Bluepoint Laboratories, this product is identified by NDC 68001-607 and is authorized under FDA application ANDA214990.

Identification & Billing

NDC Package Code
68001-607-69
Package Description
510 g in 1 BOTTLE
Product Code
68001-607
11-Digit Billing Format
68001060769
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
510 GM
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
Non-Proprietary Name
Polyethylene Glycol 3350
Substance Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POLYETHYLENE GLYCOL 3350 17 g/17g
Pharmacologic Class
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
Bluepoint Laboratories
Product Type
Human Otc Drug
FDA Application #
ANDA214990
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68001-607). Click a package code to view its specific billing and regulatory data.

68001-607-55
238 g 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 68001-607-69 identifies a specific commercial package of 510 g in 1 bottle of Polyethylene Glycol 3350, a human over the counter drug labeled by Bluepoint Laboratories. This powder, for solution is formulated for oral use and contains polyethylene glycol 3350 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 Bluepoint Laboratories on October 01, 2023. The current certification is valid through December 31, 2026.

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 Bluepoint Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68001060769. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 510 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)
68001-607-69
11-Digit CMS (5-4-2)
68001-0607-69

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