Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored Powder, For Solution
NDC Package 64380-768-21

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, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored powders is classified as a

administered via oral route. This formulation utilizes a powder, for solution delivery system. Marketed by Strides Pharma Science Limited, this product is identified by NDC 64380-768 and is authorized under FDA application ANDA204559.

Identification & Billing

NDC Package Code
64380-768-21
Package Description
4 L in 1 JUG
Product Code
64380-768
11-Digit Billing Format
64380076821
RxNorm Crosswalk
  • RxCUI: 801054 - PEG-3350 420 GM / sodium chloride 11.2 GM / sodium bicarbonate 5.72 GM / potassium chloride 1.48 GM Powder for Oral Solution
  • RxCUI: 801054 - polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution
  • RxCUI: 801054 - PEG 3350 420 GM / potassium chloride 1.48 GM / sodium bicarbonate 5.72 GM / sodium chloride 11.2 GM per 4 L Powder for Oral Solution
  • RxCUI: 801054 - PEG-3350 420 GM / KCl 1.48 GM / NaCl 11.2 GM / NaHCO3 5.72 GM Powder for 4 L Oral Solution
  • RxCUI: 801054 - POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution

Clinical Specifications

Proprietary Name
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored
Non-Proprietary Name
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored
Substance Name
Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride
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)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Strides Pharma Science Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204559
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2015
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 64380-768-21 identifies a specific commercial package of 4 l in 1 jug of Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored, a human prescription drug labeled by Strides Pharma Science Limited. This powder, for solution is formulated for oral use and contains polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride 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 Strides Pharma Science Limited on April 14, 2015. The current certification is valid through December 31, 2027.

How is this Strides Pharma Science Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64380076821. 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)
64380-768-21
11-Digit CMS (5-4-2)
64380-0768-21

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