Magnesium Sulfate

Product NDC
70518-4375
11-digit product format
705184375
Labeler code
70518
Product ID
70518-4375_38c927fd-0698-9f0a-e063-6394a90a47a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MAGNESIUM SULFATE HEPTAHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
NDA019316
Marketing category
NDA
Marketing start
2025-06-28
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
500 mg/mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
SK47B8698TMAGNESIUM SULFATE HEPTAHYDRATE10034-99-8MAGNESIUM SULFATE HEPTAHYDRATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4375-07051843750025 VIAL, SINGLE-DOSE in 1 TRAY (70518-4375-0) / 10 mL in 1 VIAL, SINGLE-DOSE (70518-4375-1) 2025-06-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Magnesium Sulfate Injection, USPREMEDYREPACK INC.2025-06-30HUMAN PRESCRIPTION DRUG LABEL1