NDC 0990-7670

Normosol-R

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

Normosol-R is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Icu Medical Inc.. The primary component is Sodium Chloride; Sodium Acetate Anhydrous; Sodium Gluconate; Potassium Chloride; Magnesium Chloride.

Product ID0990-7670_5599a86e-731e-4f3b-abf6-2dcdd60dba64
NDC0990-7670
Product TypeHuman Prescription Drug
Proprietary NameNormosol-R
Generic NameSodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-09-01
Marketing CategoryNDA / NDA
Application NumberNDA017586
Labeler NameICU Medical Inc.
Substance NameSODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
Active Ingredient Strength526 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 Through2021-12-31

Packaging

NDC 0990-7670-03

24 BAG in 1 CASE (0990-7670-03) > 500 mL in 1 BAG
Marketing Start Date2019-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0990-7670-09 [00990767009]

Normosol-R INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017586
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-01

NDC 0990-7670-03 [00990767003]

Normosol-R INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
SODIUM CHLORIDE526 mg/100mL

OpenFDA Data

SPL SET ID:0e089a44-0cee-4804-8f6f-8508508ddb5c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 800985
  • 800988
  • 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]
    • 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 Crossover Matching brand name "Normosol-R" or generic name "Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride"

    NDCBrand NameGeneric Name
    0409-7670Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
    0409-7967Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
    0990-7670Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
    0990-7967Normosol-RSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
    0409-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE
    0990-6141PhysiosolSODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE

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