Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate Solution
NDC Package 69452-428-62

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

Package Information

Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate solution is sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients.Pediatric use information is approved for Braintree Laboratories, Inc.'s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. This formulation utilizes a solution delivery system. Marketed by Bionpharma Inc.,, this product is identified by NDC 69452-428 and is authorized under FDA application ANDA204135.

Identification & Billing

NDC Package Code
69452-428-62
Package Description
2 BOTTLE, PLASTIC in 1 KIT / 177 mL in 1 BOTTLE, PLASTIC
Product Code
69452-428
11-Digit Billing Format
69452042862
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1001689 - {2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack
  • RxCUI: 1001689 - 2 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) Pack
  • RxCUI: 1120068 - magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM in 177 mL Oral Solution
  • RxCUI: 1120068 - magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution
  • RxCUI: 1120068 - Magnesium Sulfate 0.0277 MEQ/ML / K+ sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution

Clinical Specifications

Proprietary Name
Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate
Non-Proprietary Name
Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate
Substance Name
Magnesium Sulfate Anhydrous; Potassium Sulfate; Sodium Sulfate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients.Pediatric use information is approved for Braintree Laboratories, Inc.'s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Regulatory & Marketing

Labeler Name
Bionpharma Inc.,
Product Type
Human Prescription Drug
FDA Application #
ANDA204135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-15-2025
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 69452-428-62 identifies a specific commercial package of 2 bottle, plastic in 1 kit / 177 ml in 1 bottle, plastic of Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate, a human prescription drug labeled by Bionpharma Inc.,. This solution is formulated for oral use and contains magnesium sulfate anhydrous; potassium sulfate; sodium sulfate 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 Bionpharma Inc., on April 15, 2025. The current certification is valid through December 31, 2027.

How is this Bionpharma Inc., product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69452042862. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
69452-428-62
11-Digit CMS (5-4-2)
69452-0428-62

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