Polyethylene Glycol 3350 Powder, For Solution
NDC Package 57896-490-07

11-digit billing NDC: 57896049007
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Polyethylene Glycol 3350 powders is do not take more than directed unless advised by your doctorthe 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:use once a dayfill to top of white section in cap which is marked to indicate the correct dose (17 g)stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drinkdo not combine with the starch-based thickeners used for difficulty swallowingensure that the powder is fully dissolved before drinkingdo not drink if there are any clumpsdo not use more than 7 dayschildren 16 years of age or under: ask a doctor. This formulation utilizes a powder, for solution delivery system. Marketed by Gericare Pharmaceuticals, this product is identified by NDC 57896-490 and is authorized under FDA application ANDA203928.

Identification & Billing

NDC Package Code
57896-490-07
Package Description
119 g in 1 CAN
Product Code
57896-490
11-Digit Billing Format
57896049007
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
Do not take more than directed unless advised by your doctorthe 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:use once a dayfill to top of white section in cap which is marked to indicate the correct dose (17 g)stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drinkdo not combine with the starch-based thickeners used for difficulty swallowingensure that the powder is fully dissolved before drinkingdo not drink if there are any clumpsdo not use more than 7 dayschildren 16 years of age or under: ask a doctor

Regulatory & Marketing

Labeler Name
Gericare Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
ANDA203928
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-27-2022
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 (57896-490). Click a package code to view its specific billing and regulatory data.

57896-490-03
30 PACKET in 1 CARTON / 17 g in 1 PACKET (57896-490-01)
57896-490-14
238 g in 1 CAN
57896-490-30
510 g in 1 CAN
57896-490-45
765 g in 1 CAN

* 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 57896-490-07 identifies a specific commercial package of 119 g in 1 can of Polyethylene Glycol 3350, a human over the counter drug labeled by Gericare Pharmaceuticals. 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 Gericare Pharmaceuticals on October 27, 2022. The current certification is valid through December 31, 2026.

How is this Gericare Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57896049007. 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)
57896-490-07
11-Digit CMS (5-4-2)
57896-0490-07

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