NDC 70518-1607

Magnesium Sulfate

Magnesium Sulfate Heptahydrate

Magnesium Sulfate is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Magnesium Sulfate Heptahydrate.

Product ID70518-1607_7a195dc0-11e8-29b0-e053-2a91aa0aceea
NDC70518-1607
Product TypeHuman Prescription Drug
Proprietary NameMagnesium Sulfate
Generic NameMagnesium Sulfate Heptahydrate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-10-29
Marketing CategoryANDA / ANDA
Application NumberANDA206039
Labeler NameREMEDYREPACK INC.
Substance NameMAGNESIUM SULFATE HEPTAHYDRATE
Active Ingredient Strength500 mg/mL
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 70518-1607-0

25 VIAL, SINGLE-DOSE in 1 TRAY (70518-1607-0) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-10-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1607-0 [70518160700]

Magnesium Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206039
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-29
Marketing End Date2020-05-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MAGNESIUM SULFATE HEPTAHYDRATE500 mg/mL

OpenFDA Data

SPL SET ID:54b93d42-cb1a-4e35-bfd7-8dbf9e0a0323
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1658244

    • 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" or generic name "Magnesium Sulfate Heptahydrate"

    NDCBrand NameGeneric Name
    0338-1708Magnesium SulfateMagnesium Sulfate Heptahydrate
    0338-1715Magnesium SulfateMagnesium Sulfate Heptahydrate
    0338-1719Magnesium SulfateMagnesium Sulfate Heptahydrate
    0404-9902Magnesium SulfateMagnesium Sulfate
    0404-9903Magnesium SulfateMagnesium Sulfate Heptahydrate
    0409-1754Magnesium Sulfatemagnesium sulfate
    0409-2168Magnesium SulfateMAGNESIUM SULFATE
    70518-1607Magnesium SulfateMagnesium Sulfate
    70518-0950Magnesium SulfateMagnesium Sulfate
    71872-7142Magnesium SulfateMagnesium Sulfate
    71872-7055Magnesium SulfateMagnesium Sulfate
    44567-423Magnesium SulfateMagnesium Sulfate
    44567-410Magnesium SulfateMagnesium Sulfate
    44567-424Magnesium SulfateMagnesium Sulfate
    44567-420Magnesium SulfateMagnesium Sulfate
    44567-422Magnesium SulfateMagnesium Sulfate
    44567-421Magnesium SulfateMagnesium Sulfate
    50090-3323magnesium sulfatemagnesium sulfate
    51754-1000Magnesium SulfateMagnesium Sulfate
    51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATE
    52584-064Magnesium SulfateMagnesium Sulfate
    52533-099Magnesium SulfateMagnesium Sulfate
    52533-107Magnesium SulfateMagnesium Sulfate
    52584-642Magnesium SulfateMagnesium Sulfate
    52584-754Magnesium SulfateMagnesium Sulfate
    55154-9358Magnesium SulfateMagnesium Sulfate
    63323-107magnesium sulfatemagnesium sulfate
    63323-642Magnesium SulfateMagnesium Sulfate
    63323-064Magnesium SulfateMagnesium Sulfate
    63323-106magnesium sulfatemagnesium sulfate
    66298-1070Magnesium SulfateMagnesium Sulfate
    66298-1060Magnesium SulfateMagnesium Sulfate
    51662-1372MAGNESIUM SULFATEMAGNESIUM SULFATE
    51662-1390MAGNESIUM SULFATEMAGNESIUM SULFATE
    51662-1373MAGNESIUM SULFATEMAGNESIUM SULFATE
    51662-1451MAGNESIUM SULFATEMAGNESIUM SULFATE
    0363-0395Epsom SaltMagnesium sulfate
    0363-0942Epsom SaltMagnesium Sulfate
    0395-0807Humco Epson SaltMagnesium Sulfate
    0220-3267Magnesia sulphuricaMAGNESIUM 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
    0363-9820WG 110 Walgreens FoamerMAGNESIUM SULFATE HEPTAHYDRATE
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