Magnesium Sulfate In Dextrose Injection
NDC Package 44567-160-24

11-digit billing NDC: 44567016024
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Magnesium Sulfate In Dextrose (magnesium sulfate) injection is magnesium Sulfate in 5% Dextrose Injection, USP is indicated for:•Prevention of eclampsia in patients with preeclampsia•Treatment of seizures and prevention of recurrent seizures in patients with eclampsia. This formulation utilizes a injection delivery system. Marketed by Wg Critical Care, Llc, this product is identified by NDC 44567-160 and is authorized under FDA application ANDA207349.

Identification & Billing

NDC Package Code
44567-160-24
Package Description
24 BAG in 1 CARTON / 100 mL in 1 BAG (44567-160-01)
Product Code
44567-160
11-Digit Billing Format
44567016024

Clinical Specifications

Proprietary Name
Magnesium Sulfate In Dextrose
Non-Proprietary Name
Magnesium Sulfate
Substance Name
Magnesium Sulfate Heptahydrate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MAGNESIUM SULFATE HEPTAHYDRATE 1 g/100mL
Pharmacologic Class
Usage Information
Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for:•Prevention of eclampsia in patients with preeclampsia•Treatment of seizures and prevention of recurrent seizures in patients with eclampsia

Regulatory & Marketing

Labeler Name
Wg Critical Care, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207349
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-08-2016
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 44567-160-24 identifies a specific commercial package of 24 bag in 1 carton / 100 ml in 1 bag (44567-160-01) of Magnesium Sulfate In Dextrose, a human prescription drug labeled by Wg Critical Care, Llc. This injection is formulated for intravenous use and contains magnesium sulfate heptahydrate 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 Wg Critical Care, Llc on March 08, 2016. The current certification is valid through December 31, 2027.

How is this Wg Critical Care, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44567016024. 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)
44567-160-24
11-Digit CMS (5-4-2)
44567-0160-24

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