NDC 65219-258

Cardioplegic Solution

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

Cardioplegic Solution is a Intra-arterial Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi, Usa, Llc. The primary component is Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Chloride.

Product ID65219-258_9c1af4dc-3653-49cb-baa5-e916369a4e0a
NDC65219-258
Product TypeHuman Prescription Drug
Proprietary NameCardioplegic Solution
Generic NamePotassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride
Dosage FormInjection, Solution
Route of AdministrationINTRA-ARTERIAL
Marketing Start Date2022-06-06
Marketing CategoryANDA /
Application NumberANDA214623
Labeler NameFresenius Kabi, USA, LLC
Substance NameCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Active Ingredient Strength18 mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharm ClassesBlood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65219-258-10

10 POUCH in 1 CASE (65219-258-10) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (65219-258-01)
Marketing Start Date2022-06-06
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Cardioplegic Solution" or generic name "Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride"

NDCBrand NameGeneric Name
65219-258Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE
0409-7969PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE

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