Magnesium Sulfate Injection, Solution
NDC Package 0338-6353-40

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

Package Information

Magnesium Sulfate (magnesium sulfate heptahydrate) injection is magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. This formulation utilizes a injection, solution delivery system. Marketed by Baxter Healthcare Corporation, this product is identified by NDC 0338-6353 and is authorized under FDA application ANDA211966.

Identification & Billing

NDC Package Code
0338-6353-40
Package Description
40 BAG in 1 CARTON / 100 mL in 1 BAG (0338-6353-01)
Product Code
0338-6353
11-Digit Billing Format
00338635340
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Magnesium Sulfate
Non-Proprietary Name
Magnesium Sulfate Heptahydrate
Substance Name
Magnesium Sulfate Heptahydrate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MAGNESIUM SULFATE HEPTAHYDRATE 3 g/100mL
Pharmacologic Class
Usage Information
Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously 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
Baxter Healthcare Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA211966
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2026
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 0338-6353-40 identifies a specific commercial package of 40 bag in 1 carton / 100 ml in 1 bag (0338-6353-01) of Magnesium Sulfate, a human prescription drug labeled by Baxter Healthcare Corporation. This injection, solution 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 Baxter Healthcare Corporation on January 08, 2026. The current certification is valid through December 31, 2027.

How is this Baxter Healthcare Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00338635340. 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 (4-4-2)
0338-6353-40
11-Digit CMS (5-4-2)
00338-6353-40

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