Magnesium Sulfate

Product NDC
52584-642
11-digit product format
525840642
Labeler code
52584
Product ID
52584-642_512e413b-44a6-4d26-bec7-5ddeb563f1fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Magnesium Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
NDA019316
Marketing category
NDA
Marketing start
2017-01-13
Marketing end
2024-02-29
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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-642-20525840642201 VIAL, SINGLE-DOSE in 1 BAG (52584-642-20) > 20 mL in 1 VIAL, SINGLE-DOSE2017-01-130000-00-00NoNoCurrent