NDC 0990-7967

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 ID: 0990-7967_65823b99-5c8a-4ba8-b605-2717d39852c4
• NDC: 0990-7967
• Product Type: Human Prescription Drug
• Proprietary Name: Normosol-R
• Generic Name: Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-09-18
• Marketing Category: NDA / NDA
• Application Number: NDA017586
• Labeler Name: ICU Medical Inc.
• Substance Name: SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
• Active Ingredient Strength: 526 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0990-7967-09

12 POUCH in 1 CASE (0990-7967-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG

• Marketing Start Date: 2019-09-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0990-7967-09 [00990796709]

Normosol-R INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017586
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-18

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM CHLORIDE	526 mg/100mL

OpenFDA Data

• SPL SET ID: 189b8ac6-e346-454f-b501-7645590ca4f8
• Manufacturer:
  • ICU Medical Inc.
• UNII:
  • 02F3473H9O
  • NVG71ZZ7P0
  • R6Q3791S76
  • 451W47IQ8X
  • 660YQ98I10
• 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"

NDC	Brand Name	Generic Name
0409-7670	Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
0409-7967	Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
0990-7670	Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
0990-7967	Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
0409-6141	Physiosol	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE
0990-6141	Physiosol	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE