NDC 0990-7965

NORMOSOL-M AND DEXTROSE

Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate

NORMOSOL-M 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 Chloride; Potassium Acetate; Magnesium Acetate.

Product ID0990-7965_019a16e8-07c8-4dd3-a5ad-9101c9ea54a2
NDC0990-7965
Product TypeHuman Prescription Drug
Proprietary NameNORMOSOL-M AND DEXTROSE
Generic NameDextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-02-08
Marketing CategoryNDA / NDA
Application NumberNDA017610
Labeler NameICU Medical Inc.
Substance NameDEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE
Active Ingredient Strength5 g/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]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0990-7965-09

12 POUCH in 1 CASE (0990-7965-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG
Marketing Start Date2021-02-08
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "NORMOSOL-M AND DEXTROSE" or generic name "Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate"

NDCBrand NameGeneric Name
0409-7965Normosol-M and DextroseDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE
0990-7965NORMOSOL-M AND DEXTROSEdextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate

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