United States· US:63323-064_ac877c06-691b-4bc1-830b-8f4403d526d2
Magnesium Sulfate
A medicinal product containing magnesium sulfate heptahydrate, registered in United States by Fresenius Kabi USA, LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- MAGNESIUM SULFATE HEPTAHYDRATE
- Manufacturer
- Fresenius Kabi USA, LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1163323-064-43
- ndc11633230644325 VIAL, GLASS in 1 TRAY (63323-064-43) / 2 mL in 1 VIAL, GLASS (63323-064-41)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Magnesium sulfate heptahydrate in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- GermanyAbführpulverRetterspitz Gmbh & Co. Kg
- CzechiaMAGNESIUM SULFATE KALCEKSAS Kalceks, Riga
- BelgiumEziclenMayoly Pharma France
- NorwayAddex-MagnesiumFresenius Kabi Norge AS
- United KingdomPotassium chloride 0.075% (potassium 5mmol/500ml) / Glucose 10% / Calcium gluconate 0.21% / Sodium chloride 0.029% / Magnesium sulfate 0.025% (magnesium 0.5mmol/500ml) solution for infusion 500ml bottlesSpecial Order
- SwedenAddex-Magnesium 1 mmol/ml Koncentrat till infusionsvätska, lösningFresenius Kabi AB
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Cormagnesin, Magnesiumsulfat Kalceks
- Belgium · Magnesium Sulfate Kalceks, Magnesium Sulfate Sterop
- Bulgaria · Кормагнезин 200, Cormagnesin 200, Кормагнезин 400
- Cyprus · Magnesium Sulfuricum Bbp
- Czechia · Magnesium Sulfate Kalceks, Magnesium Sulfuricum Bbp
- Germany · Abführpulver, Bittersalz
- Spain · Sulfato De Magnesio Altan, Sulfato De Magnesio Basi
- Finland · Addex Magnesiumsulfaatti, Addex-Magnesiumsulfaatti
- France · Spasmag Injectable, Sulfate De Magnesium Lavoisier
- United Kingdom (Northern Ireland) · Epsom Salts Bp, Magnesium Sulfate Aurum Pharmaceuticals
- Greece · Magnesium Sulfate Demo
- Hungary · Cormagnesin, Magnesium Sulfate Kalceks
- Ireland · Magnesium Sulphate Ethypharm
- Iceland · Addex Magnesium
- Italy · Magnesio Solfato Bioindustria L.I.M., Magnesio Solfato Galenica Senese
- Lithuania · Magnesium Sulfate Heptahydrate Eletis, Magnesium Sulfate Heptahydrate Kalceks
- Latvia · Magnesium Sulfate Kalceks
- Malta · Mg Magnesium Sulphate Heptahydrate Inresa
- Netherlands · Magnesiumsulfaat Kalceks, Magnesiumsulfaat Pharmamedic
- Norway · Addex, Addex Magnesium
- Poland · Inj. Magnesii Sulfurici Polpharma, Magnesium Sulfate Kalceks
- Portugal · Sulfato De Magnésio Basi, Sulfato De Magnésio Kalceks
- Sweden · Addex-Magnesium
- Slovakia · Magnesium Sulfate Kalceks, Magnesium Sulfuricum Bbp
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/ed281649-7b8b-4a82-95be-653b99b0548d GET /v1/drugs/ed281649-7b8b-4a82-95be-653b99b0548d?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAMUSCULAR; INTRAVENOUS",
"source": "ndc",
"strength": "500",
"substance": "MAGNESIUM SULFATE HEPTAHYDRATE",
"productndc": "63323-064",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA019316",
"marketing_category": "NDA"
}See everything about magnesium sulfate heptahydrate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.