NDC 63323-108

Magnesium Sulfate in 5% Dextrose

Magnesium Sulfate Heptahydrate

Magnesium Sulfate in 5% Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Magnesium Sulfate Heptahydrate.

Product ID63323-108_25b72d61-4905-42ca-945c-33acd9130b61
NDC63323-108
Product TypeHuman Prescription Drug
Proprietary NameMagnesium Sulfate in 5% Dextrose
Generic NameMagnesium Sulfate Heptahydrate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-03-07
Marketing CategoryANDA / ANDA
Application NumberANDA206486
Labeler NameFresenius Kabi USA, LLC
Substance NameMAGNESIUM SULFATE HEPTAHYDRATE
Active Ingredient Strength1 g/100mL
Pharm ClassesCalculi 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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-108-26

24 BAG in 1 CASE (63323-108-26) > 100 mL in 1 BAG (63323-108-02)
Marketing Start Date2016-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-108-02 [63323010802]

Magnesium Sulfate in 5% Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206486
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-07

NDC 63323-108-26 [63323010826]

Magnesium Sulfate in 5% Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206486
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-03-07

NDC 63323-108-00 [63323010800]

Magnesium Sulfate in 5% Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206486
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-24

NDC 63323-108-01 [63323010801]

Magnesium Sulfate in 5% Dextrose INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206486
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-03-07

Drug Details

Active Ingredients

IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE1 g/100mL

OpenFDA Data

SPL SET ID:cea3f48b-375a-415a-a341-435c09719f7c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 829757

    • Pharmacological Class

    • 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 Crossover Matching brand name "Magnesium Sulfate in 5% Dextrose" or generic name "Magnesium Sulfate Heptahydrate"

    NDCBrand NameGeneric Name
    63323-108Magnesium Sulfate in 5% DextroseMagnesium Sulfate in 5% Dextrose
    59779-541CVS foaming muscle reliefMagnesium Sulfate heptahydrate
    22431-124Epsom SaltsMagnesium Sulfate Heptahydrate
    0220-3267Magnesia sulphuricaMAGNESIUM SULFATE HEPTAHYDRATE
    0338-1708Magnesium SulfateMagnesium Sulfate Heptahydrate
    0338-1715Magnesium SulfateMagnesium Sulfate Heptahydrate
    0338-1719Magnesium SulfateMagnesium Sulfate Heptahydrate
    0404-9903Magnesium SulfateMagnesium Sulfate Heptahydrate
    25021-612Magnesium SulfateMagnesium Sulfate Heptahydrate
    47335-992MAGNESIUM SULFATEmagnesium sulfate heptahydrate
    50090-3323magnesium sulfateMAGNESIUM SULFATE HEPTAHYDRATE
    51754-1000Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATE
    52584-754Magnesium SulfateMagnesium Sulfate Heptahydrate
    55154-9358Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATE
    0264-4400Magnesium Sulfate in Dextrosemagnesium sulfate heptahydrate
    0264-4204Magnesium Sulfate in Watermagnesium sulfate heptahydrate
    0264-4205Magnesium Sulfate in Watermagnesium sulfate heptahydrate
    0264-4206Magnesium Sulfate in Watermagnesium sulfate heptahydrate
    22431-248Relief Epsom SaltMagnesium Sulfate Heptahydrate
    61594-003Theraworx Relief Muscle Cramp and Spasm ReliefMAGNESIUM SULFATE HEPTAHYDRATE
    61594-004Theraworx Relief Muscle Cramp and Spasm ReliefMAGNESIUM SULFATE HEPTAHYDRATE
    0363-9820WG 110 Walgreens FoamerMAGNESIUM SULFATE HEPTAHYDRATE
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