Home › NDC Lookup › Ingredients › Magnesium Sulfate › 00404-9904-02
💉image loading
(from DailyMed)

Magnesium Sulfate 500 mg/mL Injection, Solution

by Henry Schein, Inc. · 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9904-02) / 2 mL in 1 VIAL, SINGLE-DOSE
NDC 00404-9904-02
🏷️ FDA NDC (as labeled) 0404-9904-02 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 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

FDA NDC (as labeled) 0404-9904-02
Product NDC 0404-9904
11-digit billing NDC 00404990402
RxCUI 1658221
UNII SK47B8698T
Application # NDA019316
SPL Set ID 5176ed24-015e-43fe-9eb4-85098debf5f1
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 2022-01-18
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance MAGNESIUM SULFATE HEPTAHYDRATE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 0404-9904-02 — a 4-4-2 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 labeler segment → 00404-9904-02. 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.

🏭 Manufacturer & labeler

LabelerHenry Schein, Inc.
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA019316 (NDA)
Labeler code00404
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio171 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Most people see results somewhere between 30 minutes and 6 hours after taking it. That's a pretty wide window, so just be prepared and stay close to a bathroom after your dose. Don...
  • Yes, and water really matters here. You need to dissolve your dose in a full 8-ounce glass of water and drink all of it. The water helps the magnesium do its job in your intestines...
  • Does it matter how I take it — like with food or water?
  • This product is designed for occasional constipation — not everyday use. If you find you need a laxative for more than one week straight, that's your sign to talk to a doctor. Rely...
📖 Read our full Magnesium Sulfate guide →
6
Nutrient depletion considerations

Magnesium Sulfate (prescription drug) may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Magnesium Sulfate (prescription drug) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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.

💲 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
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)0404-9904-02
11-digit billing NDC00404-9904-02
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ3475
DescriptorInjection, magnesium sulfate, per 500 mg
Billing units / pkg2 units
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Magnesium Sulfate 500 mg/mLthis 00404-9904-02 Henry 1 vial — AP FDA listed —
Magnesium Sulfate 500 mg/mL 31722-0394-32 Camber 25 vials — AP FDA listed —
Magnesium Sulfate 500 mg/mL 51662-1390-01 HF 2 ml — AP FDA listed —
Magnesium Sulfate 500 mg/mL 63323-0064-23 Fresenius 25 vials — AP FDA listed —
Magnesium Sulfate 500 mg/mL 71872-7142-01 Medical 1 vial — AP FDA listed —
Magnesium Sulfate 500 mg/mL 51662-1372-01 HF 20 ml — AP FDA listed —
Magnesium Sulfate 500 mg/mL 00409-1754-10 Hospira, 1 syringe — AP FDA listed —
Magnesium Sulfate 500 mg/mL 00409-2168-77 Hospira, 25 vials — AP FDA listed —
Magnesium Sulfate 500 mg/mL 00404-9902-20 Henry 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00404-9904-02 You're viewing this 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9904-02) / 2 mL in 1 VIAL, SINGLE-DOSE 2022-01-18 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 FDA registers it as 0404-9904-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00404-9904-02, written without dashes as 00404990402. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00404-9904-02, the first segment (00404) is the labeler code FDA assigned to Henry Schein, Inc.; the middle segment (9904) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Henry Schein, Inc. 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🎯 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 5.2 mEq/L) or elevated. In total parental nutrition (TPN), magnesium sulfate may be added to the nutriend 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 beyone 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 sever 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% Dextros Injection, USP or 0.9% Sodium Chloride Injection, USP for slow IV infusion over a three-hour period. In the treatment of dificiency states, caution must be observed to prevent exceeding the renal excretory capacity.

In Hyperalimentation In TPN, maintenence 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 administer1 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 IV o…

⛔ 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 of kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immautre, 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. Thissue 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 convulsion.

🤒 Adverse Reactions 51 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 CNS depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.

🆘 Overdosage 123 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.

🧬 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 stlres 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 impuls. 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. 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 only larger doses cause lowering of blood pressure. The central and peripheral effects of magnesium poisoning are antagonized ot some extent by IV administration of calcium.

Pharmakokinetics 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 111 words ▾

HOW SUPPLIED Above products packaged in plastic vials. Product number with a "P" suffix indicates vial is partially filled. Do not administer unless solution is clear and seal is intact.

Contains no preservative. Discard unused portion. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 63323-064-03 25 in 1 CARTON NDC 0404-9904-02 1 2 mL Glass Vial in a bag (Vial bears NDC 63323-064-01) 500 mg/mL Magnesium mg/ml

49.3Sulfate mg/mL 194.7 Image2.jpg

📋 Description 159 words ▾

Descriptipn 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: 4060 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 2O, with a molecular weight of 246.47 and occurs as colorless crystals or white powder freely soluble in water.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00404-9903-10 · Henry 00404-9905-50 · Henry →
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.