NDC 0409-7969

Plegisol

Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride

Plegisol is a Intra-arterial Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Potassium Chloride; Sodium Chloride; Calcium Chloride; Magnesium Chloride.

• Product ID: 0409-7969_224dc671-8218-4e24-9e43-d73bc7f6b0ef
• NDC: 0409-7969
• Product Type: Human Prescription Drug
• Proprietary Name: Plegisol
• Generic Name: Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRA-ARTERIAL
• Marketing Start Date: 2005-07-28
• Marketing Category: NDA / NDA
• Application Number: NDA018608
• Labeler Name: Hospira, Inc.
• Substance Name: POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
• Active Ingredient Strength: 119 mg/100mL; mg/100mL; mg/100mL; mg/100mL
• Pharm Classes: Potassium Compounds [CS],Potassium Salt [EPC],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],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],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 0409-7969-05

12 POUCH in 1 CASE (0409-7969-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (0409-7969-11)

• Marketing Start Date: 2005-07-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-7969-05 [00409796905]

Plegisol INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA018608
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-07-28

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM CHLORIDE	119.3 mg/100mL

OpenFDA Data

• SPL SET ID: 35a174f0-f0d7-4ec7-3f81-d3d572c059cf
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • M4I0D6VV5M
  • 02F3473H9O
  • 451W47IQ8X
  • 660YQ98I10

Pharmacological Class

• Potassium Compounds [CS]
• Potassium Salt [EPC]
• 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]
• Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Calcium [CS]
• Cations
• Divalent [CS]
• 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]
• Potassium Compounds [CS]
• Potassium Salt [EPC]
• 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]
• Blood Coagulation Factor [EPC]
• Increased Coagulation Factor Activity [PE]
• Calcium [CS]
• Cations
• Divalent [CS]
• 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 "Plegisol" or generic name "Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride"

NDC	Brand Name	Generic Name
0409-7969	Plegisol	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE
65219-258	Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE