Polyethylene Glycol (3350) Powder, For Solution
NDC Package 51079-306-30

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) powders is •do not take more than directed unless advised by your doctor•adults and children 17 years of age and older:•stir and dissolve the contents of one pouch (17 g) into any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink•use once a day•use no more than 7 days•children 16 years of age or under: ask a doctor. This formulation utilizes a powder, for solution delivery system. Marketed by Mylan Institutional Inc., this product is identified by NDC 51079-306 and is authorized under FDA application ANDA078915.

Identification & Billing

NDC Package Code
51079-306-30
Package Description
30 POUCH in 1 CARTON / 17 g in 1 POUCH (51079-306-01)
Product Code
51079-306
11-Digit Billing Format
51079030630
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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 3500
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 3500 17 g/17g
Usage Information
•do not take more than directed unless advised by your doctor•adults and children 17 years of age and older:•stir and dissolve the contents of one pouch (17 g) into any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink•use once a day•use no more than 7 days•children 16 years of age or under: ask a doctor

Regulatory & Marketing

Labeler Name
Mylan Institutional Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA078915
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-12-2009
Listing Expiration
12-31-2027
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 51079-306-30 identifies a specific commercial package of 30 pouch in 1 carton / 17 g in 1 pouch (51079-306-01) of Polyethylene Glycol (3350), a human over the counter drug labeled by Mylan Institutional Inc.. This powder, for solution is formulated for oral use and contains polyethylene glycol 3500 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 Mylan Institutional Inc. on October 12, 2009. The current certification is valid through December 31, 2027.

How is this Mylan Institutional Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51079030630. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
51079-306-30
11-Digit CMS (5-4-2)
51079-0306-30

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