Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate Solution
NDC Package 43386-700-83

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, 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 adults. This formulation utilizes a solution delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 43386-700 and is authorized under FDA application ANDA202511.

Identification & Billing

NDC Package Code
43386-700-83
Package Description
2 BOTTLE in 1 CARTON / 177 mL in 1 BOTTLE
Product Code
43386-700
11-Digit Billing Format
43386070083
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, Magnesium Sulfate
Non-Proprietary Name
Sodium Sulfate, Potassium Sulfate, 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 adults.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202511
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-30-2022
Listing Expiration
12-31-2026
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 43386-700-83 identifies a specific commercial package of 2 bottle in 1 carton / 177 ml in 1 bottle of Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate, a human prescription drug labeled by Lupin Pharmaceuticals, 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 Lupin Pharmaceuticals, Inc. on December 30, 2022. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386070083. 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)
43386-700-83
11-Digit CMS (5-4-2)
43386-0700-83

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