NDC 0409-7968

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 Hospira, Inc.. The primary component is Dextrose, Unspecified Form; Sodium Chloride; Sodium Acetate Anhydrous; Sodium Gluconate; Potassium Chloride; Magnesium Chloride.

• Product ID: 0409-7968_608af034-7053-498a-bed8-a7ae2b46025f
• NDC: 0409-7968
• Product Type: Human Prescription Drug
• Proprietary Name: Normosol-R and Dextrose
• Generic Name: Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-09-16
• Marketing Category: NDA / NDA
• Application Number: NDA017609
• Labeler Name: Hospira, Inc.
• Substance Name: DEXTROSE, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
• Active Ingredient Strength: 5 g/100mL; 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: 2020-12-31

Packaging

NDC 0409-7968-09

12 BAG in 1 CASE (0409-7968-09) > 1000 mL in 1 BAG

• Marketing Start Date: 2010-09-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-7968-09 [00409796809]

Normosol-R and Dextrose INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017609
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-09-16

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROSE, UNSPECIFIED FORM	5 g/100mL

OpenFDA Data

• SPL SET ID: 50265baf-0232-45cf-7388-31c0bbfbc2a3
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 02F3473H9O
  • 451W47IQ8X
  • IY9XDZ35W2
  • R6Q3791S76
  • NVG71ZZ7P0
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 1189629
  • 801024

Pharmacological Class

• 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]
• 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 and Dextrose" or generic name "Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride"

NDC	Brand Name	Generic Name
0409-7968	Normosol-R and Dextrose	Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride
0990-7968	Normosol-R and Dextrose	Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride