MAGNESIUM SULFATE 40 mg/mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Osmotically acting laxatives class.
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🏭 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
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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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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII O40UQP6WCF
A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.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 | $0.6336 | $63.36 / 100 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 40 mg/mL 25021-0612-81 | Sagent | 50 ml | — | AP | FDA listed | — |
| magnesium sulfate 40 mg/mL 63323-0106-01 | Fresenius | 100 ml | — | AP | FDA listed | — |
| Magnesium Sulfate 40 mg/mLthis 47335-0992-02 | Sun | 1 pouch | — | AP | FDA listed | — |
Where does this data come from?
⏳ 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
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 47335-0992-01 | 1 BAG in 1 POUCH (47335-992-01) / 50 mL in 1 BAG | 2021-08-01 | Active |
| 47335-0992-02 You're viewing this | 1 BAG in 1 POUCH (47335-992-02) / 100 mL in 1 BAG | 2021-08-01 | Active |
This pack accounts for about 12% 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 47335-0992-02?
What NDC number is used to bill for this package of MAGNESIUM SULFATE 40 mg/mL 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 | ✓ Available |
| Inactive ingredients (structured) | ✓ 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
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Magnesium Sulfate in Water for Injection 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 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 Water for Injection may be administered intravenously.
The rate of I.V. infusion should generally not exceed 150 mg/minute, or 3.75 mL of a 4% 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 I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. 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 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.
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy (See WARNINGS and PRECAUTIONS) Teratogenic Effects: Magnesium Sulfate in Water for Injection can cause fetal abnormalities when administered beyond 5 to 7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization’s, osteopenia and other skeletal abnormalities with continuous maternal administration of magnesium sulfate for more than 5 to 7 days. 1-12 Magnesium Sulfate in Water for Injection should be used during pregnancy only if clearly needed.
If this drug is used during pregnancy the woman should be apprised of the potential harm to the fetus. Nonteratogenic Effects: When administered by continuous IV infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of magnesium toxicity, including neuromuscular or respiratory depression. (See OVERDOSAGE. )
🆘 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.
🧬 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
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Magnesium Sulfate in Water for Injection is supplied as clear colorless solution in single-dose flexible plastic containers as follows: NDC No. Size Container Total Magnesium Sulfate** Total Magnesium Ion Magnesium Sulfate** Concentration Magnesium Ion Concentration Osmolarity (Calc.) 47335-992-01 50 mL* 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 mOsmol/Liter 47335-992-02 100 mL 4 g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 mOsmol/Liter * Partial fill container 50 mL volume in 100 mL container. ** As the heptahydrate.
WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
📋 Description ▾
DESCRIPTION Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate 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 4% concentration. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium sulfate heptahydrate, USP is chemically designated MgSO 4 • 7H 2 O, colorless crystals or white powder freely soluble in water.
Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polypropylene. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.
Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F 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.