Magnesium Sulfate in Water

Product NDC
0409-3164
11-digit product format
004093164
Labeler code
0409
Product ID
0409-3164_e435d27c-001a-4a01-8be4-76f18e577db6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MAGNESIUM SULFATE IN WATER
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA020309
Marketing category
NDA
Marketing start
2023-06-19
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
40 g/1000mL
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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-3164-120040931641212 POUCH in 1 CASE (0409-3164-12) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG (0409-3164-01) 12 pouch2023-06-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MAGNESIUM SULFATE IN WATER FOR INJECTIONHospira, Inc.2026-04-23HUMAN PRESCRIPTION DRUG LABEL30