Winco Powder, For Solution
NDC Package 67091-447-08

11-digit billing NDC: 67091044708
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Winco (polyethylene glycol 3350) powders is •do not take more than directed unless advised by your doctor•the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)•adults and children 17 years of age and older: ouse once a dayofill to top of white section in cap which is marked to indicate the correct dose (17 g)ostir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drinkodo not combine with starch-based thickeners used for difficulty swallowingoensure that the powder is fully dissolved before drinkingodo not drink if there are any clumpsodo not 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 Winco Foods, this product is identified by NDC 67091-447 and is authorized under FDA application ANDA202071.

Identification & Billing

NDC Package Code
67091-447-08
Package Description
238 g in 1 BOTTLE, PLASTIC
Product Code
67091-447
11-Digit Billing Format
67091044708
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
Winco
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
•do not take more than directed unless advised by your doctor•the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)•adults and children 17 years of age and older: ouse once a dayofill to top of white section in cap which is marked to indicate the correct dose (17 g)ostir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drinkodo not combine with starch-based thickeners used for difficulty swallowingoensure that the powder is fully dissolved before drinkingodo not drink if there are any clumpsodo not use no more than 7 days•children 16 years of age or under: ask a doctor

Regulatory & Marketing

Labeler Name
Winco Foods
Product Type
Human Otc Drug
FDA Application #
ANDA202071
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-21-2023
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 67091-447-08 identifies a specific commercial package of 238 g in 1 bottle, plastic of Winco, a human over the counter drug labeled by Winco Foods. 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 Winco Foods on August 21, 2023. The current certification is valid through December 31, 2027.

How is this Winco Foods product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67091044708. 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)
67091-447-08
11-Digit CMS (5-4-2)
67091-0447-08

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