Polyethylene Glycol 3350 Powder
NDC Package 57449-009-01

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Polyethylene Glycol 3350 powders is a medication used to treat occasional constipation. This formulation utilizes a powder delivery system. Marketed by Avesta Pharma Private Limited, this product is identified by NDC 57449-009.

Identification & Billing

NDC Package Code
57449-009-01
Package Description
1 BAG in 1 SUPERSACK / 700 kg in 1 BAG
Product Code
57449-009
11-Digit Billing Format
57449000901

Clinical Specifications

Proprietary Name
Polyethylene Glycol 3350
Non-Proprietary Name
Polyethylene Glycol 3350
Substance Name
Polyethylene Glycol 3350
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
POLYETHYLENE GLYCOL 3350 1 kg/kg
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
Avesta Pharma Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
06-01-2014
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (57449-009). Click a package code to view its specific billing and regulatory data.

57449-009-02
1 BAG in 1 BAG / 25 kg in 1 BAG
57449-009-03
1 BAG in 1 SUPERSACK / 500 kg in 1 BAG
57449-009-04
1 BAG in 1 SUPERSACK / 1000 kg in 1 BAG

* 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 57449-009-01 identifies a specific commercial package of 1 bag in 1 supersack / 700 kg in 1 bag of Polyethylene Glycol 3350 (UNFINISHED drug), a bulk ingredient labeled by Avesta Pharma Private Limited. This powder is formulated for 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 Avesta Pharma Private Limited on June 01, 2014. The current certification is valid through December 31, 2027.

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 Avesta Pharma Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57449000901. 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)
57449-009-01
11-Digit CMS (5-4-2)
57449-0009-01

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