Polyethylene Glycol 3350 Nf
NDC Package 42576-180-28

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Polyethylene Glycol 3350 Nf 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 (clear section in cap)adults and children 17 years of age and older:○ fill to top of clear 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 drink○ use once a day○ use no more than 7 dayschildren 16 years of age or under: ask a doctor. Marketed by Nuvo Pharmaceutical Inc., this product is identified by NDC 42576-180 and is authorized under FDA application ANDA206105.

Identification & Billing

NDC Package Code
42576-180-28
Package Description
238 g in 1 BOTTLE
Product Code
42576-180
11-Digit Billing Format
42576018028
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 Nf
Dosage Form
-
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 (clear section in cap)adults and children 17 years of age and older:○ fill to top of clear 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 drink○ use once a day○ use no more than 7 dayschildren 16 years of age or under: ask a doctor

Regulatory & Marketing

Labeler Name
Nuvo Pharmaceutical Inc.
FDA Application #
ANDA206105
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-03-2017
Listing Expiration
12-31-2018
Exclude Flag
I
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 (42576-180). Click a package code to view its specific billing and regulatory data.

42576-180-19
119 g in 1 BOTTLE
42576-180-50
510 g in 1 BOTTLE

* 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 42576-180-28 identifies a specific commercial package of 238 g in 1 bottle of Polyethylene Glycol 3350 Nf, labeled by Nuvo Pharmaceutical Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nuvo Pharmaceutical Inc. on July 03, 2017. The current certification is valid through December 31, 2018.

How is this Nuvo Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42576018028. 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)
42576-180-28
11-Digit CMS (5-4-2)
42576-0180-28

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