Polyethylene Glycol 3350 Nf
NDC Package 58607-700-57

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 1. Marketed by Martin Ekwealor Pharmaceuticals, Inc., this product is identified by NDC 58607-700.

Identification & Billing

NDC Package Code
58607-700-57
Package Description
527 g in 1 BOTTLE
Product Code
58607-700
11-Digit Billing Format
58607070057
RxNorm Crosswalk
  • RxCUI: 1488067 - PEGyLAX 17 GM Powder for Oral Solution
  • RxCUI: 1488067 - polyethylene glycol 3350 17000 MG Powder for Oral Solution [Pegylax]
  • RxCUI: 1488067 - Pegylax 17 GM Powder for Oral Solution
  • 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 Pegylax
Dosage Form
-
Usage Information
1. Note: This product cap is for dosing. A capful contains about 17 grams of powder.2. Daily dose is 17 grams per day or as directed by physician.3. pour 17 grams (about 1 heaping tablespoon) of powder into a cup.4. Stir the powder in 4 to 8 oz. of water, juice, soda, coffee or tea until completely dissolved.5. Drink the solution.6. Treatment for 2 to 4 days may required to produce a bowel movement.Keep this and all medications out of the reach of children.Store at 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30°(59° - 86° F). (See USP Controlled Room Temperature)Lot # and Exp. Date:Open here for more product information

Regulatory & Marketing

Labeler Name
Martin Ekwealor Pharmaceuticals, Inc.
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
12-16-2013
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58607-700-57 identifies a specific commercial package of 527 g in 1 bottle of Polyethylene Glycol 3350 Nf Pegylax, labeled by Martin Ekwealor Pharmaceuticals, 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 Martin Ekwealor Pharmaceuticals, Inc. on December 16, 2013. The current certification is valid through December 31, 2017.

How is this Martin Ekwealor Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58607070057. 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)
58607-700-57
11-Digit CMS (5-4-2)
58607-0700-57

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