Magnesium Sulfate

Product NDC
52584-064
11-digit product format
525840064
Labeler code
52584
Product ID
52584-064_726e8889-beab-423b-9e9e-bb449956e0bc
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
2015-09-16
Marketing end
0000-00-00
Substance
MAGNESIUM SULFATE HEPTAHYDRATE
Active strength
500 mg/mL
Pharmacologic classes
Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-064-01525840064011 VIAL, SINGLE-DOSE in 1 BAG (52584-064-01) > 2 mL in 1 VIAL, SINGLE-DOSE2018-04-050000-00-00NoNoCurrent