Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral Solution
NDC Package 64380-116-01

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 Oral 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 and pediatric patients 12 years of age and older. This formulation utilizes a solution delivery system. Marketed by Strides Pharma Science Limited, this product is identified by NDC 64380-116 and is authorized under FDA application ANDA215469.

Identification & Billing

NDC Package Code
64380-116-01
Package Description
2 BOTTLE in 1 CARTON / 177 mL in 1 BOTTLE (64380-116-02)
Product Code
64380-116
11-Digit Billing Format
64380011601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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
  • RxCUI: 1120068 - Magnesium Sulfate 0.0277 MEQ/ML / Pot sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution
  • RxCUI: 1120068 - magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM per 177 ML Oral Solution

Clinical Specifications

Proprietary Name
Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral
Non-Proprietary Name
Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral
Substance Name
Magnesium Sulfate, Unspecified Form; 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 and pediatric patients 12 years of age and older.

Regulatory & Marketing

Labeler Name
Strides Pharma Science Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA215469
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-17-2024
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 64380-116-01 identifies a specific commercial package of 2 bottle in 1 carton / 177 ml in 1 bottle (64380-116-02) of Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate Oral, a human prescription drug labeled by Strides Pharma Science Limited. This solution is formulated for oral use and contains magnesium sulfate, unspecified form; 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 Strides Pharma Science Limited on January 17, 2024. 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: 64380011601. 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)
64380-116-01
11-Digit CMS (5-4-2)
64380-0116-01

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