Polyethylene Glycol 3350 Powder, For Solution
NDC Package 51672-2104-3

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

Package Information

Polyethylene Glycol 3350 (instalax polyethylene glycol 3350) powders is a medication used to treat occasional constipation. This formulation utilizes a powder, for solution delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-2104 and is authorized under FDA application ANDA203928.

Identification & Billing

NDC Package Code
51672-2104-3
Package Description
765 g in 1 CAN
Product Code
51672-2104
11-Digit Billing Format
51672210403
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
765 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
Instalax 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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA203928
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-09-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51672-2104-3 identifies a specific commercial package of 765 g in 1 can of Polyethylene Glycol 3350, a human over the counter drug labeled by Sun Pharmaceutical Industries, Inc.. 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 Sun Pharmaceutical Industries, Inc. on October 09, 2025. 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 Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672210403. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 765 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 (5-4-1)
51672-2104-3
11-Digit CMS (5-4-2)
51672-2104-03

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