NDC 0990-7372

Ionosol MB and Dextrose

Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate

Ionosol MB and Dextrose is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Icu Medical Inc.. The primary component is Dextrose Monohydrate; Sodium Lactate; Potassium Chloride; Magnesium Chloride; Monobasic Potassium Phosphate; Sodium Phosphate, Monobasic, Monohydrate.

Product ID0990-7372_141f724f-c654-4793-998c-2d1e18e74e25
NDC0990-7372
Product TypeHuman Prescription Drug
Proprietary NameIonosol MB and Dextrose
Generic NameDextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-07-01
Marketing CategoryNDA / NDA
Application NumberNDA019513
Labeler NameICU Medical Inc.
Substance NameDEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; MONOBASIC POTASSIUM PHOSPHATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active Ingredient Strength5 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharm ClassesOsmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],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],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0990-7372-03

24 POUCH in 1 CASE (0990-7372-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG
Marketing Start Date2020-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0990-7372-03 [00990737203]

Ionosol MB and Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-01-01

NDC 0990-7372-62 [00990737262]

Ionosol MB and Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL

OpenFDA Data

SPL SET ID:1b457b1d-0e80-4578-ba6f-dedf513fc962
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 800644
  • 800648
  • Pharmacological Class

    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Potassium Compounds [CS]
    • Potassium Salt [EPC]
    • Calculi Dissolution Agent [EPC]
    • Magnesium Ion Exchange Activity [MoA]
    • Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Potassium Compounds [CS]
    • Potassium Salt [EPC]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • 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]
    • Potassium Compounds [CS]
    • Potassium Salt [EPC]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]

    NDC Crossover Matching brand name "Ionosol MB and Dextrose" or generic name "Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate"

    NDCBrand NameGeneric Name
    0409-7372Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
    0990-7372Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

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