Magnesium Sulfate
NDC Package 54868-5724-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Magnesium Sulfate is injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5724 and is authorized under FDA application ANDA075151.

Identification & Billing

NDC Package Code
54868-5724-0
Package Description
25 CARTON in 1 CONTAINER / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC
Product Code
54868-5724
11-Digit Billing Format
54868572400
RxNorm Crosswalk
  • RxCUI: 829762 - magnesium sulfate 5 GM in 10 ML Prefilled Syringe
  • RxCUI: 829762 - 10 ML magnesium sulfate 500 MG/ML Prefilled Syringe
  • RxCUI: 829762 - magnesium sulfate 5 GM per 10 ML (4 mEq/ML) Prefilled Syringe
  • RxCUI: 829762 - magnesium sulfate 5 GM per 10 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Magnesium Sulfate
Dosage Form
-
Usage Information
Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) or elevated.In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.Magnesium Sulfate Injection, USP is also indicated as a parenteral anticonvulsant for the prevention and control of seizures (convulsions) in severe toxemia of pregnancy. It effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA075151
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-12-2006
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-5724-0 identifies a specific commercial package of 25 carton in 1 container / 1 syringe, plastic in 1 carton / 10 ml in 1 syringe, plastic of Magnesium Sulfate, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on December 12, 2006. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868572400. 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 (5-4-1)
54868-5724-0
11-Digit CMS (5-4-2)
54868-5724-00

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