"68083-397-01" National Drug Code (NDC)

NDC Code	68083-397-01
Package Description	24 POUCH in 1 CASE (68083-397-01) > 1 BAG in 1 POUCH > 100 mL in 1 BAG
Product NDC	68083-397
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Magnesium Sulfate
Non-Proprietary Name	Magnesium Sulfate Heptahydrate
Dosage Form	INJECTION, SOLUTION
Usage	INTRAVENOUS
Start Marketing Date	20200710
Marketing Category Name	ANDA
Application Number	ANDA213917
Manufacturer	Gland Pharma Limited
Substance Name	MAGNESIUM SULFATE HEPTAHYDRATE
Strength	4
Strength Unit	g/100mL
Pharmacy 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]