NDC 0990-7968

Normosol-R and Dextrose

Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride

Normosol-R 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, Unspecified Form; Sodium Chloride; Sodium Acetate Anhydrous; Sodium Gluconate; Potassium Chloride; Magnesium Chloride.

Product ID0990-7968_603465f1-e106-4247-b1f2-8171dffac0a6
NDC0990-7968
Product TypeHuman Prescription Drug
Proprietary NameNormosol-R and Dextrose
Generic NameDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-05-14
Marketing CategoryNDA / NDA
Application NumberNDA017609
Labeler NameICU Medical Inc.
Substance NameDEXTROSE, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
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],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],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 0990-7968-09

12 BAG in 1 CASE (0990-7968-09) > 1000 mL in 1 BAG
Marketing Start Date2020-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0990-7968-09 [00990796809]

Normosol-R and Dextrose INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017609
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

Drug Details

NDC Crossover Matching brand name "Normosol-R and Dextrose" or generic name "Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride"

NDCBrand NameGeneric Name
0409-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride
0990-7968Normosol-R and DextroseDextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride

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