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magnesium sulfate 40 mg/mL Injection, Solution — NDC 63323-0106-01 package photo
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magnesium sulfate 40 mg/mL Injection, Solution — NDC 63323-106-01 (Billing 63323-0106-01)

by Fresenius Kabi USA, LLC · 24 BAG in 1 CASE / 100 mL in 1 BAG

This is a package of magnesium sulfate 40 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Mar 2016 and currently FDA-listed.

NDC 63323-0106-01
🏷️ FDA NDC (as labeled) 63323-106-01 billing pads the product segment with a zero
This package
Contains100 mL in 1 bag Medicaid pays$1.20 / unit · 12 mo Per package$2,884.32 / 2400 ml · Medicaid Pack sizes5 compare ↓
Product page 63323-0106-05 Also comes in: 50 ml 63323-106-05 50 ml 63323-106-26 500 ml 63323-106-15 1000 ml 63323-106-10
Rx only Generic 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-106-01
Product NDC 63323-106
11-digit billing NDC 63323010601
NCPDP billing unit ML — per mL (volume)
RxCUI 829734, 1658259, 1658262, 1658264, 1658265
UNII SK47B8698T
Application # ANDA206485
SPL Set ID fef9e18c-5210-4090-b564-4950ebe461c0
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-03-15
Route 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 79400010402045
GPI class Magnesium Sulfate
GCN Seq No 063347
GCN 99097
HICL code 039652
Ingredient (HICL) Magnesium Sulfate In Water
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 SULF 4 G/100 ML BAG
FDB brand name Magnesium Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063347
  • GCN: 99097
  • GPI-14 (Medi-Span): 79400010402045
  • HICL (First Databank): 039652
  • AHFS class code: 24:04.04.92
  • RxCUI (RxNorm): 829734
Why two NDCs? The FDA registers this code as 63323-106-01 — 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 → 63323-0106-01. 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 SULF 4 G/100 ML BAG Ingredient Magnesium Sulfate In Water
📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $1.20 $2,884.32 / 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 —
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)63323-106-01
11-digit billing NDC63323-0106-01
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 / pkg0.08 units
How the units are derivedThis package is 100 ML; the HCPCS unit is 500 MG, so one package = 0.08 billing units.
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
63323-0106-01 You're viewing this 24 BAG in 1 CASE / 100 mL in 1 BAG 2016-03-15 — Active
63323-0106-05 63323-106-05 Main listing 24 BAG in 1 CASE / 50 mL in 1 BAG 2016-03-15 — Active
63323-0106-10 63323-106-10 24 BAG in 1 CASE / 1000 mL in 1 BAG 2016-03-15 — Active
63323-0106-15 63323-106-15 24 BAG in 1 CASE / 500 mL in 1 BAG 2016-03-15 — Active
63323-0106-26 63323-106-26 24 BAG in 1 CASE / 50 mL in 1 BAG 2016-03-15 — Active

This pack accounts for about 6.9% 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 — 24 bag in 1 case / 100 ml in 1 bag.
What NDC number is used to bill for this package of magnesium sulfate 40 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 40 mg/mL 25021-0612-81 Sagent 50 ml — AP FDA listed —
magnesium sulfate 40 mg/mLthis 63323-0106-01 Fresenius 100 ml — AP FDA listed —
Magnesium Sulfate 40 mg/mL 47335-0992-01 Sun 1 pouch — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Mar 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 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.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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 applicationANDA206485 (ANDA)
Labeler code63323
First marketedMar 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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 58 words ▾

INDICATIONS AND USAGE Magnesium sulfate in water for injection 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 ~3 min read ▾

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 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 water for injection may be administered intravenously.

The rate of IV 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 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 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 water for injection may be administered intravenously. The rate of IV 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 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 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 19 words ▾

CONTRAINDICATIONS Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

⚠️ Warnings 124 words ▾

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 53 words ▾

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 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 (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 ~1 min read ▾

HOW SUPPLIED Magnesium Sulfate in Water for Injection is supplied in single-dose flexible containers as follows: Product Code Unit of Sale Total Magnesium Sulfate* Total Magnesium Ion Magnesium Sulfate* Concentration Magnesium Ion Concentration Osmolarity (calc.) Unit of Use 610605 NDC 63323-106-05 Unit of 24 2 g 16.25 mEq 4% (40 mg/mL) 16.25 mEq/50 mL 325 m0smol/Liter NDC 63323-106-02 50 mL fill in a 100 mL free flex Bag 610601 NDC 63323-106-01 Unit of 24 4g 32.5 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 m0smol/Liter NDC 63323-106-00 100 mL fill in a 100 mL free flex Bag 610615 NDC 63323-106-15 Unit of 24 20 g 162.3 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 m0smol/Liter NDC for unit of use not present on Labeling 500 mL fill in a 500 mL free flex Bag 610610 NDC 63323-106-10 Unit of 24 40 g 325 mEq 4% (40 mg/mL) 32.5 mEq/100 mL 325 m0smol/Liter NDC for unit of use not present on Labeling 1,000 mL fill in a 1,000 mL free flex Bag 610705 NDC 63323-107-05 Unit of 24 4 g 32.5 mEq 8% (80 mg/mL) 32.5 mEq/50 mL 649 m0smol/Liter NDC 63323-107-01 50 mL fill in a 100 mL free flex Bag *As the heptahydrate.

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS. This container is not made with natural rubber latex or polyvinyl chloride (PVC), Non-DEHP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from freezing.

📋 Description 218 words ▾

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% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium sulfate, USP heptahydrate 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 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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS 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 every four hours. 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/minute). Serum magnesium levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). The strength of the deep tendon reflexes begins to diminish when serum magnesium levels exceed 4 mEq/liter.

Reflexes may be absent at 10 mEq magnesium/liter, 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 in water for injection should be administered slowly to avoid producing hypermagnesemia.

Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with magnesium sulfate in water for injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pregnancy Teratogenic Effects Pregnancy Category D ( see WARNINGS and PRECAUTIONS ) . See WARNINGS and PRECAUTIONS .

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 ). Labor and Delivery Continuous administration of magnesium sulfate is an unapproved treatment for preterm labor.

The safety and efficacy of such use have not been established. The administration of magnesium sulfate in water for injection outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when magnesium sulfate in water for injection is administered to a nursing mother.

Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with magnesium sulfate in water for injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy Teratogenic Effects Pregnancy Category D ( see WARNINGS and PRECAUTIONS ) . See WARNINGS and PRECAUTIONS . 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… [Excerpted — this section continues on DailyMed.]

📚 References ~1 min read ▾

REFERENCES Yokoyama K, Takahashi N, Yada Y. Prolonged maternal magnesium administration and bone metabolism in neonates. Early Human Dev .

2010; 86(3):187-91. Epub 2010 Mar 12. Wedig KE, Kogan J, Schorry EK et al.

Skeletal demineralization and fractures caused by fetal magnesium toxicity. J Perinatol . 2006; 26(6):371-4.

Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of magnesium sulfate tocolysis. Acta Obstet Gynecol Scan .

2006; 85(9):1099-103. Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received magnesium sulphate for tocolysis of premature labor.

Pediatr Radiol . 2004; 34(5):384-6. Epub 2004 Feb 18.

Matsuda Y, Maeda Y, Ito M, et al. Effect of magnesium sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest .

1997; 44(2):82-8. Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous magnesium sulfate therapy on neonatal calcium metabolism and bone mineral content.

Gynecol Obstet Invest. 1997; 43(4):236-41. Santi MD, Henry GW, Douglas GL.

Magnesium sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthop . 1994; 14(2):249-53.

Holocomb WL, Shackelford GD, Petrie RH. Magnesium tocolysis and neonatal bone abnormalities: a controlled study. Obstet Gynecol .

1991; 78(4):611-4. Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate.

Am J Roentgenol . 1989; 152(5):1071-2. Lamm CL, Norton KL, Murphy RJ.

Congenital rickets associated with magnesium sulfate infusion for tocolysis. J Pediatr . 1988; 113(6):1078-82.

McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of magnesium sulfate treatment on perinatal calcium metabolism. II.

Neonatal responses. Obstet Gynecol . 1980; 56(5):595-600.

Riaz M, Porat R, Brodsky NL, et al. The effect of maternal magnesium sulfate treatment on newborns: a prospective controlled study. J Perinatol.

1998; 18(6 pt 1):449-54.

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

PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Foil Overwrap PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Bag Label NDC 63323-106-02 Magnesium Sulfate in Water for Injection 2 g total in 50 mL (0.325 mEq Mg ++ /mL) 40 mg per mL 2 g TOTAL For Intravenous Infusion Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Bag Case Label Product No. 610605 Magnesium Sulfate in Water for Injection 2 g total in 50 mL (40 mg per mL) NDC 63323-106-05 Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Bag Foil Overwrap PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Bag Label NDC 63323-107-01 Magnesium Sulfate in Water for Injection 4 g total in 50 mL (0.65 mEq Mg ++/mL) 80 mg per mL 4 g TOTAL For Intravenous Infusion Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Bag Case Label Product No.

610705 Magnesium Sulfate in Water for Injection 4 g total in 50 mL (80 mg per mL) NDC 63323-107-05 Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 100 mL Bag Foil Overwrap PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 100 mL Bag Label NDC 63323-106-00 Magnesium Sulfate in Water for Injection 4 g total in 100 mL (0.325 mEq Mg ++ /mL) 40 mg per mL 4 g TOTAL For Intravenous Infusion Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY - Magnesium Sulfate 50 mL Bag Case Label Product No. 610601 Magnesium Sulfate in Water for Injection 4 g total in 100 mL (40 mg per mL) For Intravenous Infusion NDC 63323-106-01 Rx only foil foil bag case foil foil bag case foil foil bag case

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
1.7K
Units reimbursed last 4 qtrs
174.5K
Gross reimbursed last 4 qtrs
$209.7K
Avg / prescription
$120.17
Avg / unit
$1.2018
Latest quarter Q1 2026
191Rx
Fee-for-service vs managed care ⓘ
12% FFS 88% MCO
Fee-for-service · 208 Rx Managed care · 1,537 Rx
State Medicaid map
Alaska: 7,600 units · 1,037 per 100k residents AK Maine: no data reported ME Washington: 23,600 units · 302 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 40,088 units · 205 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,413 units · 33.4 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 6,575 units · 205 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 13,100 units · 111 per 100k residents OH Pennsylvania: 5,000 units · 38.6 per 100k residents PA New Jersey: 6,140 units · 66.1 per 100k residents NJ Massachusetts: no data reported MA California: 6,088 units · 15.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 6,113 units · 309 per 100k residents NE Missouri: 3,600 units · 58.1 per 100k residents MO Kentucky: 9,587 units · 212 per 100k residents KY West Virginia: 13,550 units · 766 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 1,700 units · 57.8 per 100k residents KS Arkansas: no data reported AR Tennessee: 5,204 units · 73.0 per 100k residents TN North Carolina: 9,213 units · 85.0 per 100k residents 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: 3,200 units · 29.0 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 6,425 units · 21.1 per 100k residents TX Florida: 6,300 units · 27.9 per 100k residents FL
Units reimbursed · per 100k residents
15.61,037
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 Alaska 1,037 /100k
2 West Virginia 766 /100k
3 Nebraska 309 /100k
4 Washington 302 /100k
5 Kentucky 212 /100k
6 Iowa 205 /100k
7 New York 205 /100k
8 Ohio 111 /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.
50 ml63323-0106-05 14,246 Rx · $652,798
1000 ml63323-0106-10 6,261 Rx · $1,991,051
100 ml this page63323-0106-01 1,745 Rx · $209,703
50 ml63323-0106-26 1,654 Rx · $47,943
500 ml63323-0106-15 1,295 Rx · $56,351
Drug total (last 4 qtrs): 25,201 Rx · 3,422,547 units · $2,957,846 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) ✓ 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 4 other package presentations of this same product, including 50 ml (63323-0106-05), 50 ml (63323-0106-26), 500 ml (63323-0106-15). 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.
← 63323-0104-05 · Fresenius 63323-0107-05 · Fresenius →
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.