Magnesium Sulfate Injection, Solution
NDC Package 76483-129-05
Package Information
Magnesium Sulfate (magnesium sulfate heptahydrate) injection is 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 level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) 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 is also indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. This formulation utilizes a injection, solution delivery system. Marketed by Square Pharmaceuticals Plc., this product is identified by NDC 76483-129 and is authorized under FDA application ANDA217461.
Identification & Billing
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Intravenous - Administration within or into a vein or veins.
- Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
Regulatory & Marketing
Hierarchy Structure
- 76483 - Square Pharmaceuticals Plc.
- 76483-129 - Magnesium Sulfate
- 76483-129-05 - 25 VIAL in 1 CARTON / 20 mL in 1 VIAL (76483-129-04)
- 76483-129 - Magnesium Sulfate
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (76483-129). Click a package code to view its specific billing and regulatory data.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 76483-129-05 identifies a specific commercial package of 25 vial in 1 carton / 20 ml in 1 vial (76483-129-04) of Magnesium Sulfate, a human prescription drug labeled by Square Pharmaceuticals Plc.. This injection, solution is formulated for intramuscular; 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 Square Pharmaceuticals Plc. on October 30, 2026. The current certification is valid through December 31, 2027.
How is this Square Pharmaceuticals Plc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 76483012905. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.