Magnesium Sulfate 500 mg/mL Injection, Solution — NDC 63323-0642-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Magnesium Sulfate 500 mg/mL Injection, Solution — NDC 63323-642-20 (Billing 63323-0642-20)

by Fresenius Kabi USA, LLC · 25 VIAL, SINGLE-DOSE in 1 TRAY / 20 mL in 1 VIAL, SINGLE-DOSE

This is a package of Magnesium Sulfate 500 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Jan 2016 and currently FDA-listed.

NDC 63323-0642-20
🏷️ FDA NDC (as labeled) 63323-642-20 billing pads the product segment with a zero
This package
Contains20 mL in 1 vial, single-dose Medicaid pays$25.80 / unit · 12 mo Per package$12,899.10 / 500 ml · Medicaid Pack sizes2 compare ↓
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 63323-642-20 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 642 product · 20 package
Package marketed since
Jan 29, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0363323642020, 0363323642013
Medicaid fills, this package
5,965 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-642-20
Product NDC 63323-642
11-digit billing NDC 63323064220
NCPDP billing unit ML — per mL (volume)
RxCUI 1658236, 1658245
UNII SK47B8698T
UPC 0363323642020, 0363323642013
Application # NDA019316
SPL Set ID 77f70e00-3934-4fd9-a581-4cf3df8c42d2
Established class (EPC) Calculi Dissolution Agent; Osmotic Activity
Mechanism of action Magnesium Ion Exchange Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption; Inhibition Small Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-01-29
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance MAGNESIUM SULFATE HEPTAHYDRATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79400010402020
GPI class Magnesium Sulfate
GCN Seq No 001417
GCN 04163
HICL code 000610
Ingredient (HICL) Magnesium Sulfate
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1H
Therapeutic class — specific (HIC3) Magnesium Salts Replacement
AHFS code 24:04.04.92
AHFS class Antiarrhythmics, Miscellaneous
FDB label name MAGNESIUM SULFATE 50% 10G/20ML
FDB brand name Magnesium Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001417
  • GCN: 04163
  • GPI-14 (Medi-Span): 79400010402020
  • HICL (First Databank): 000610
  • AHFS class code: 24:04.04.92
  • RxCUI (RxNorm): 1658236
Why two NDCs? The FDA registers this code as 63323-642-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63323-0642-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Osmotically acting laxatives class.

Drug family (ATC) Osmotically acting laxatives, Magnesium, Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name MAGNESIUM SULFATE 50% 10G/20ML Ingredient Magnesium Sulfate
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Injections treat low magnesium and prevent and control seizures in preeclampsia and eclampsia. Oral products such as Epsom Salts relieve occasional const...
  • Dissolve the dose in a full glass (8 ounces) of water and drink it, with extra liquid as directed. A bowel movement usually comes in ½ to 6 hours. Follow the age-based package dire...
  • Flushing, sweating, low blood pressure, drowsiness and weaker reflexes are the most common. Your care team watches for these and checks your magnesium levels.
  • What side effects should I expect with the injection?
📖 Read our full Magnesium Sulfate Heptahydrate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $25.80 $12,899.10 / 500 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 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)63323-642-20
11-digit billing NDC63323-0642-20
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3475
DescriptorINJECTION, MAGNESIUM SULFATE, PER 500 MG
Billing units / pkg1 units
How the units are derivedThis package is 20 ML; the HCPCS unit is 500 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$38,598 · 26,029 claims · $1.48 per claim (all NDCs under J3475)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0642-20 You're viewing this 25 VIAL, SINGLE-DOSE in 1 TRAY / 20 mL in 1 VIAL, SINGLE-DOSE 2016-01-29 — Active
63323-0642-50 63323-642-50 Main listing 25 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE 2016-01-29 — Active

This pack accounts for about 25% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 25 vial, single-dose in 1 tray / 20 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Magnesium Sulfate 500 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Magnesium Sulfate 500 mg/mLthis 63323-0642-20 Fresenius 25 vials — AP FDA listed —
Magnesium Sulfate 500 mg/mL 71872-7229-01 Medical 1 vial — AP FDA listed —
Magnesium Sulfate 500 mg/mL 84549-0064-11 ProPharma 10 ml — AP FDA listed —
Magnesium Sulfate 500 mg/mL 63323-0064-23 Fresenius 25 vials — AP FDA listed —
Magnesium Sulfate 500 mg/mL 70518-4375-00 REMEDYREPACK 25 vials — AP FDA listed —
Magnesium Sulfate 500 mg/mL 00404-9903-10 Henry 1 syringe — AP FDA listed —
Magnesium Sulfate 500 mg/mL 31722-0394-32 Camber 25 vials — AP FDA listed —
Magnesium Sulfate 500 mg/mL 71872-7142-01 Medical 1 vial — AP FDA listed —
Magnesium Sulfate 500 mg/mL 71872-7381-01 Medical 1 vial — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Jan 2016
📍
2026
Currently FDA-listed
10 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Magnesium Sulfate Heptahydrate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA019316 (NDA)
Labeler code63323
First marketedJan 2016
Product typeHuman Prescription Drug
Portfolio554 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 107 words ▾

INDICATIONS AND USAGE: 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.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION: Dosage of magnesium sulfate must be carefully adjusted according to individual requirements and response, and administration of the drug should be discontinued as soon as the desired effect is obtained. Both IV and IM administration are appropriate. IM administration of the undiluted 50% solution results in therapeutic plasma levels in 60 minutes, whereas IV doses will provide a therapeutic level almost immediately.

The rate of IV injection should generally not exceed 150 mg/minute (1.5 mL of a 10% concentration or its equivalent), except in severe eclampsia with seizures (see below). Continuous maternal administration of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. Solutions for IV infusion must be diluted to a concentration of 20% or less prior to administration.

The diluents commonly used are 5% Dextrose Injection, USP and 0.9% Sodium Chloride Injection, USP. Deep IM injection of the undiluted (50%) solution is appropriate for adults, but the solution should be diluted to a 20% or less concentration prior to such injection in children. In Magnesium Deficiency In the treatment of mild magnesium deficiency, the usual adult dose is 1 g, equivalent to 8.12 mEq of magnesium (2 mL of the 50% solution) injected IM every six hours for four doses (equivalent to a total of 32.5 mEq of magnesium per 24 hours).

For severe hypomagnesemia, as much as 250 mg (approximately 2 mEq) per kg of body weight (0.5 mL of the 50% solution) may be given IM within a period of four hours if necessary. Alternatively, 5 g (approximately 40 mEq) can be added to one liter of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP for slow IV infusion over a three-hour period. In the treatment of deficiency states, caution must be observed to prevent exceeding the renal excretory capacity.

In Hyperalimentation In TPN, maintenance requirements for magnesium are not precisely known. The maintenance dose used in adults ranges from 8 to 24 mEq (1 to 3 g) daily; for infants, the range is 2 to 10 mEq (0.25 to 1.25 g) daily. In Pre-eclampsia or Eclampsia In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate.

Intravenously, a dose of 4 to 5 g in 250 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP may be infused. Simultaneously, IM doses of up to 10 g (5 g or 10 mL of the undiluted 50% solution in each buttock) are given. Alternatively, the initial IV dose of 4 g may be given by diluting the 50% solution to a 10 or 20% concentration; the diluted fluid (40 mL of a 10% solution or 20 mL of a 20% solution) may then be injected IV over a period of three to four minutes.

Subsequently, 4 to 5 g (8 to 10 mL of the 50% solution) are injected IM into alternate buttocks every four hours as needed, depending on the continuing presence of the patellar reflex and adequate respiratory function. Alternatively, after the initial IV dose, some clinicians administer 1 to 2 g/hour by constant IV infusion. 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 should not be exceeded. In the presence of severe renal insufficiency, the maximum dosage of magnesium sulfate is 20 grams/48 hours and frequent serum magnesium concentrations must be obtained.

Continuous use of magnesium sulfate in pregnancy beyond 5 to 7 days can cause fetal abnormalities. Other uses In counteracting the muscle-stimulating effects of barium poisoning, the usual dose of magnesium sulfate is 1 to 2 g given IV. For controlling seizures associated with epilepsy, glomerulonephritis or hypothyroidism, the usual adult dose is 1 g administered IM or IV.

In paroxysmal atrial tachycardia, magnesium should be used only if simpler measures have failed and there is no evidence of myocardial damage. The usual dose is 3 to 4 g (30 to 40 mL of a 10% solution) administered… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS: Parenteral administration of the drug is contraindicated in patients with heart block or myocardial damage.

⚠️ Warnings ~1 min read ▾

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.

ALUMINUM TOXICITY: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.

IV use in eclampsia should be reserved for immediate control of life-threatening convulsions.

🤒 Adverse Reactions 69 words ▾

ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 CNS depression proceeding to respiratory paralysis.

Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.

🤰 Pregnancy 23 words ▾

Nursing Mothers Since magnesium is distributed into milk during parenteral magnesium sulfate administration, the drug should be used with caution in nursing women.

🆘 Overdosage 190 words ▾

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 ~2 min read ▾

CLINICAL PHARMACOLOGY: Magnesium is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. As a nutritional adjunct in hyperalimentation, the precise mechanism of action for magnesium is uncertain. Early symptoms of hypomagnesemia (less than 1.5 mEq/L) may develop as early as three to four days or within weeks.

Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of magnesium. While there are large stores of magnesium present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels.

Parenteral magnesium therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease. 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 (CNS), but it does not adversely affect the woman, fetus or neonate when used as directed in eclampsia or pre-eclampsia.

Normal plasma magnesium levels range from 1.5 to 2.5 mEq/L. As plasma magnesium rises above 4 mEq/L, the deep tendon reflexes are first decreased and then disappear as the plasma level approaches 10 mEq/L. At this level respiratory paralysis may occur.

Heart block also may occur at this or lower plasma levels of magnesium. Serum magnesium concentrations in excess of 12 mEq/L may be fatal. 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 IV administration of calcium. Pharmacokinetics With IV administration the onset of anticonvulsant action is immediate and lasts about 30 minutes.

Following IM 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/L. Magnesium is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

Pharmacokinetics With IV administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following IM 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/L. Magnesium is excreted solely by the kidneys at a rate proportional to the plasma concentration and glomerular filtration.

📦 How Supplied / Storage and Handling 88 words ▾

HOW SUPPLIED: Product Code Unit of Sale Strength Magnesium mg/mL Sulfate mg/mL Each 642120 NDC 63323-642-20 Unit of 25 10 grams per 20 mL (500 mg per mL) 49.3 194.7 NDC 63323-642-01 20 mL Single-dose Vial 642150 NDC 63323-642-50 Unit of 25 25 grams per 50 mL (500 mg per mL) 49.3 194.7 NDC 63323-642-02 50 mL Single-dose Vial Do not administer unless solution is clear and seal is intact. Preservative free. Discard unused portion.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 161 words ▾

DESCRIPTION: Magnesium Sulfate Injection, USP 50% is a sterile, nonpyrogenic, concentrated solution of magnesium sulfate heptahydrate in Water for Injection. It is administered by the intravenous (IV) or intramuscular (IM) routes as an electrolyte replenisher or anticonvulsant. Must be diluted before IV use.

Each mL contains: Magnesium sulfate heptahydrate 500 mg; water for injection, q.s. Sulfuric acid and/or sodium hydroxide may have been added for pH adjustment. The pH of a 5% solution is between 5.5 and 7.0.

(Osmolarity: 4,060 mOsmol/L (calc.); 2.03 mM/mL magnesium sulfate anhydrous; 4.06 mEq/mL magnesium sulfate anhydrous). The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single dose injection. When smaller doses are required the unused portion should be discarded with the entire unit.

Magnesium sulfate heptahydrate is chemically designated MgSO 4 •7H 2 O, with a molecular weight of 246.47 and occurs as colorless crystals or white powder freely soluble in water.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS: General Administer with caution if flushing and sweating occurs. When barbiturates, narcotics or other hypnotics (or systemic anesthetics) are to be given in conjunction with magnesium, their dosage should be adjusted with caution because of additive CNS depressant effects of magnesium. Because magnesium is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment.

Urine output should be maintained at a level of 100 mL or more during the four hours preceding each dose. Monitoring serum magnesium levels and the patient’s clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/min).

When repeated doses of the drug are given parenterally, knee jerk reflexes should be tested before each dose and if they are absent, no additional magnesium should be given until they return. Serum magnesium levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/L). The strength of the deep tendon reflexes begins to diminish when magnesium levels exceed 4 mEq/L.

Reflexes may be absent at 10 mEq magnesium/L, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium intoxication in eclampsia. Magnesium sulfate injection (50%) must be diluted to a concentration of 20% or less prior to IV infusion.

Rate of administration should be slow and cautious, to avoid producing hypermagnesemia. The 50% solution also should be diluted to 20% or less for IM injection in infants and children. Laboratory Tests Magnesium sulfate injection should not be given unless hypomagnesemia has been confirmed and the serum concentration of magnesium is monitored.

The normal serum level is 1.5 to 2.5 mEq/L. Drug Interactions CNS Depressants –When barbiturates, narcotics or other hypnotics (or systemic anesthetics), or other CNS depressants are to be given in conjunction with magnesium, their dosage should be adjusted with caution because of additive CNS depressant effects of magnesium. CNS depression and peripheral transmission defects produced by magnesium may be antagonized by calcium.

Neuromuscular Blocking Agents –Excessive neuromuscular block has occurred in patients receiving parenteral magnesium sulfate and a neuromuscular blocking agent; these drugs should be administered concomitantly with caution. Cardiac Glycosides –Magnesium sulfate should be administered with extreme caution in digitalized patients, because serious changes in cardiac conduction which can result in heart block may occur if administration of calcium is required to treat magnesium toxicity. Pregnancy Teratogenic Effects: Pregnancy Category D (see WARNINGS and PRECAUTIONS ) See WARNINGS and PRECAUTIONS .

Magnesium sulfate 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, osteopenia and other skeletal abnormalities with continuous maternal administration of magnesium sulfate for more than 5 to 7 days. 1-10 Magnesium sulfate 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 hazard 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 ). Labor and Delivery Continuous administration of magnesium sulfate is an unapproved treatment for preterm labor.

The safety and efficacy of such use have not be… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 20 mL Vial Label NDC 63323-642-01 642120 Magnesium Sulfate Injection, USP 50% 10 grams per 20 mL (500 mg per mL) For intramuscular or intravenous use. MUST BE DILUTED BEFORE INTRAVENOUS USE. Preservative free. 20 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 20 mL Vial Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 20 mL Tray Label NDC 63323-642-20 642120 Magnesium Sulfate Injection, USP 50% 10 grams per 20 mL (500 mg per mL) For intramuscular or intravenous use. MUST BE DILUTED BEFORE INTRAVENOUS USE. Preservative free. 25 x 20 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 20 mL Tray Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Vial Label NDC 63323-642-02 642150 Magnesium Sulfate Injection, USP 50% 25 grams per 50 mL (500 mg per mL) For intramuscular or intravenous use. MUST BE DILUTED BEFORE INTRAVENOUS USE. Preservative free. 50 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Vial Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Tray Label NDC 63323-642-50 642150 Magnesium Sulfate Injection, USP 50% 25 grams per 50 mL (500 mg per mL) For intramuscular or intravenous use. MUST BE DILUTED BEFORE INTRAVENOUS USE. Preservative free. 25 x 50 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Tray Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6K
Units reimbursed last 4 qtrs
98.9K
Gross reimbursed last 4 qtrs
$2.55M
Avg / prescription
$427.55
Avg / unit
$25.7983
Latest quarter Q1 2026
1.4KRx
Fee-for-service vs managed care ⓘ
80% FFS 20% MCO
Fee-for-service · 4,762 Rx Managed care · 1,203 Rx
State Medicaid map
Alaska: 1,055 units · 144 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 1,060 units · 17.9 per 100k residents WI Michigan: 2,352 units · 23.4 per 100k residents MI New York: 5,379 units · 27.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 703 units · 16.6 per 100k residents OR Nevada: 197 units · 6.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,706 units · 13.6 per 100k residents IL Indiana: no data reported IN Ohio: 7,263 units · 61.6 per 100k residents OH Pennsylvania: 83 units · 0.6 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 49,150 units · 126 per 100k residents CA Utah: no data reported UT Colorado: 18,854 units · 321 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 295 units · 6.5 per 100k residents KY West Virginia: no data reported WV Virginia: 412 units · 4.7 per 100k residents VA Maryland: 1,938 units · 31.4 per 100k residents MD Connecticut: 517 units · 14.3 per 100k residents CT Rhode Island: no data reported RI Arizona: 340 units · 4.6 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 6,939 units · 97.4 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 138 units · 1.3 per 100k residents GA D.C.: no data reported DC Hawaii: 56 units · 3.9 per 100k residents HI Texas: no data reported TX Florida: 418 units · 1.8 per 100k residents FL
Units reimbursed · per 100k residents
0.6321
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Colorado 321 /100k
2 Alaska 144 /100k
3 California 126 /100k
4 Tennessee 97.4 /100k
5 Ohio 61.6 /100k
6 Maryland 31.4 /100k
7 New York 27.5 /100k
8 Michigan 23.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
25 vials63323-0642-50 17,436 Rx · $8,469,695
25 vials this page63323-0642-20 5,965 Rx · $2,550,309
Drug total (last 4 qtrs): 23,401 Rx · 634,121 units · $11,020,004 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Magnesium Sulfate — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Magnesium Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$64.1K
Claims incl. refills
2.6K
Beneficiaries
506
Spend / beneficiary
$126.60
Spend / claim
$24.56
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Magnesium Sulfate (this brand).

Top reported reactions

Nausea837
Pyrexia791
Pain704
Foetal Exposure During Pregnancy687
Premature Baby672
Diarrhoea639
Dyspnoea595

Age at onset

Neonate400
Infant63
Child52
Adolescent37
Adult897
Elderly653

Reporter sex

12,819 reports
Male · 40%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization6,673
Life-threatening1,909
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,096 360
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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) — 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
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 25 vials (63323-0642-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3475 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.