Trilyte Powder, For Solution
NDC Package 84386-013-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Trilyte (polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride) powders is tRILYTE is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. This formulation utilizes a powder, for solution delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 84386-013 and is authorized under FDA application ANDA076491.

Identification & Billing

NDC Package Code
84386-013-04
Package Description
4 L in 1 BOTTLE
Product Code
84386-013
11-Digit Billing Format
84386001304
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
Trilyte
Non-Proprietary Name
Polyethylene Glyocol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride
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
Usage Information
TRILYTE is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA076491
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2026
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 84386-013-04 identifies a specific commercial package of 4 l in 1 bottle of Trilyte, a human prescription drug labeled by Aurobindo Pharma 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 Aurobindo Pharma Limited on April 14, 2026. The current certification is valid through December 31, 2027.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84386001304. 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)
84386-013-04
11-Digit CMS (5-4-2)
84386-0013-04

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