Magnesium Sulfate in 5% Dextrose Magnesium Sulfate Heptahydrate 1 g/100mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Osmotically acting laxatives class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- It's being used to protect you and your baby from seizures related to your preeclampsia. Magnesium helps calm the nerve and muscle signals that can lead to seizures — it essentiall...
- I was told I'd be getting magnesium sulfate during my delivery. What is it actually doing for me?
- The most common ones are flushing, warmth, and sweating — many people describe a feeling of heat spreading through their body when the infusion starts. You might also feel drowsy o...
- What side effects should I expect from the IV magnesium?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.2919 | $700.56 / 2400 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J3475 | $0.446 / J3475 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Magnesium Sulfate in Dextrose 10 mg/mL 00264-4400-54 | B. | 100 ml | — | AP | FDA listed | — |
| Magnesium Sulfate In Dextrose 10 mg/mL 00338-1709-40 | Baxter | 100 ml | — | AP | FDA listed | — |
| Magnesium Sulfate in Dextrose 10 mg/mL 00409-6727-23 | Hospira, | 24 pouches | — | AP | FDA listed | — |
| Magnesium Sulfate in Dextrose 1 g/100mL 44567-0410-24 | WG | 100 ml | — | AP | FDA listed | — |
| Magnesium Sulfate in 5% Dextrose 1 g/100mLthis 63323-0108-26 | Fresenius | 100 ml | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0108-26 You're viewing this | 24 BAG in 1 CASE (63323-108-26) / 100 mL in 1 BAG (63323-108-02) | 2016-03-07 | Active |
| 63323-0108-01 | 24 BAG in 1 CASE (63323-108-01) / 100 mL in 1 BAG (63323-108-00) | 2016-03-07 | Active |
This pack accounts for about 26% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 63323-0108-26?
What NDC number is used to bill for this package of Magnesium Sulfate in 5% Dextrose Magnesium Sulfate Heptahydrate 1 g/100mL Injection, Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Magnesium sulfate in 5% dextrose injection, USP is indicated for the prevention and control of seizures in pre-eclampsia 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Magnesium sulfate in 5% dextrose injection, USP is intended for intravenous use only. For the management of pre-eclampsia or eclampsia, intravenous infusions of dilute solutions of magnesium (1% to 8%) are often given in combination with intramuscular injections of 50% magnesium sulfate injection, USP. Therefore, in the clinical conditions cited below, both forms of therapy are noted, as appropriate.
Continuous maternal administration of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. In Pre-eclampsia or Eclampsia In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. To initiate therapy, 4 g of magnesium sulfate in 5% dextrose injection, USP may be administered intravenously.
The rate of IV infusion should generally not exceed 150 mg/minute, or 7.5 mL of a 2% concentration (or its equivalent) per minute, except in severe eclampsia with seizures. Simultaneously, 4 to 5 g (32.5 to 40.6 mEq) of magnesium sulfate may be administered intramuscularly into each buttock using undiluted 50% magnesium sulfate injection, USP. After the initial IV dose, some clinicians administer 1 to 2 g/hour by constant IV infusion.
Subsequent intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into alternate buttocks every four hours, depending on the continuing presence of the patellar reflex, adequate respiratory function, and absence of signs of magnesium toxicity. Therapy should continue until paroxysms cease. A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures.
A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should not be exceeded. In the presence of severe renal insufficiency, frequent serum magnesium concentrations must be obtained, and the maximum recommended dosage of magnesium sulfate is 20 g per 48 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not administer unless solution is clear. Discard unused portion.
In Pre-eclampsia or Eclampsia In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. To initiate therapy, 4 g of magnesium sulfate in 5% dextrose injection, USP may be administered intravenously. The rate of IV infusion should generally not exceed 150 mg/minute, or 7.5 mL of a 2% concentration (or its equivalent) per minute, except in severe eclampsia with seizures.
Simultaneously, 4 to 5 g (32.5 to 40.6 mEq) of magnesium sulfate may be administered intramuscularly into each buttock using undiluted 50% magnesium sulfate injection, USP. After the initial IV dose, some clinicians administer 1 to 2 g/hour by constant IV infusion. Subsequent intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into alternate buttocks every four hours, depending on the continuing presence of the patellar reflex, adequate respiratory function, and absence of signs of magnesium toxicity.
Therapy should continue until paroxysms cease. A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should not be exceeded.
In the presence of severe renal insufficiency, frequent serum magnesium concentrations must be obtained, and the maximum recommended dosage of magnesium sulfate is 20 g per 48 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless solution is clear.
Discard unused portion.
⛔ Contraindications ▾
CONTRAINDICATIONS: Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.
⚠️ Warnings ▾
WARNINGS: FETAL HARM: Continuous administration of magnesium sulfate beyond 5 to 7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported.
The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed. If magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5 to 7 days may cause fetal abnormalities.
Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.
🆘 Overdosage ▾
OVERDOSAGE: Magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected IV to antagonize the effects of magnesium.
For Treatment of Overdose Artificial respiration is often required. Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable) with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.
Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as IV calcium.
For Treatment of Overdose Artificial respiration is often required. Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable) with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.
Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as IV calcium.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Magnesium (Mg ++ ) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. Magnesium prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Magnesium is said to have a depressant effect on the central nervous system, but it does not adversely affect the mother, fetus or neonate when used as directed in eclampsia or pre-eclampsia.
Normal serum magnesium levels range from 1.3 to 2.1 mEq/liter. As serum magnesium rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the serum level approaches 10 mEq/liter. At this level respiratory paralysis may occur.
Heart block also may occur at this or lower serum levels of magnesium. Magnesium acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure.
The central and peripheral effects of magnesium poisoning are antagonized to some extent by intravenous administration of calcium. With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours.
Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter. Pharmacokinetics Absorption Intravenously administered magnesium is immediately absorbed. Distribution Approximately 1 to 2% of total body magnesium is located in the extracellular fluid space.
Magnesium is 30% bound to albumin. Metabolism Magnesium is not metabolized. Excretion Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.
Special Populations Renal Insufficiency Magnesium is excreted solely by the kidney. In patients with severe renal insufficiency, the dose should be lower and frequent serum magnesium levels must be obtained (see DOSAGE AND ADMINISTRATION ). Hepatic Insufficiency Magnesium is excreted solely by the kidney.
No dosing adjustments are necessary in hepatic insufficiency. Drug-Drug Interactions Drug induced renal losses of magnesium occur with the following drugs or drug classes: Aminoglycosides Amphotericin B Cyclosporine Diuretics Digitalis Cisplatin Alcohol
Pharmacokinetics Absorption Intravenously administered magnesium is immediately absorbed. Distribution Approximately 1 to 2% of total body magnesium is located in the extracellular fluid space. Magnesium is 30% bound to albumin. Metabolism Magnesium is not metabolized. Excretion Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.
Special Populations Renal Insufficiency Magnesium is excreted solely by the kidney. In patients with severe renal insufficiency, the dose should be lower and frequent serum magnesium levels must be obtained (see DOSAGE AND ADMINISTRATION ). Hepatic Insufficiency Magnesium is excreted solely by the kidney.
No dosing adjustments are necessary in hepatic insufficiency. Drug-Drug Interactions Drug induced renal losses of magnesium occur with the following drugs or drug classes: Aminoglycosides Amphotericin B Cyclosporine Diuretics Digitalis Cisplatin Alcohol
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in a single dose flexible plastic container as follows: Product Code Unit of Sale Total Magnesium Sulfate* Total Magnesium Ion Magnesium Sulfate* Concentration Magnesium Ion Concentration Osmolarity (calc.) Unit of Use PRX610801 63323-108-26 Package of 24 1 g 8.1 mEq 1% (10 mg/mL) 8.1 mEq/100 mL 333 mOsmol/Liter 63323-108-02 100 mL fill in a 100 mL free flex ® Bag *As the heptahydrate. WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.
The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from freezing.
📋 Description ▾
DESCRIPTION: Magnesium Sulfate in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate and dextrose in water for injection. Each 100 mL contains 1 g magnesium sulfate heptahydrate and dextrose, hydrous 5 g in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment.
The pH is 4.5 (3.5 to 6.5). It is available in a 1% concentration. See HOW SUPPLIED section for the content and characteristics of available dosage form and size.
Magnesium sulfate, USP heptahydrate is chemically designated MgSO 4 • 7H 2 O, colorless crystals or white powder freely soluble in water. Dextrose, USP is chemically designated D-glucose, monohydrate, a hexose sugar freely soluble in water. It has the following structural formula: C 6 H 12 O 6 • H 2 O M.W.
198.17 Water for injection, USP is chemically designated H 2 O. The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.
Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content.
Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. structure