<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83634-500-83
</NDCCode>
<PackageDescription>
30 POUCH in 1 CARTON (83634-500-83) / 1 BAG in 1 POUCH (83634-500-41) / 50 mL in 1 BAG
</PackageDescription>
<NDC11Code>
83634-0500-83
</NDC11Code>
<ProductNDC>
83634-500
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Magnesium Sulfate In Water
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Magnesium Sulfate In Water
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20240422
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA209642
</ApplicationNumber>
<LabelerName>
Avenacy, LLC
</LabelerName>
<SubstanceName>
MAGNESIUM SULFATE HEPTAHYDRATE
</SubstanceName>
<StrengthNumber>
40
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_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]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-10-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250915
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>