"65219-258-10" National Drug Code (NDC)

Cardioplegic Solution 10 POUCH in 1 CASE (65219-258-10) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (65219-258-01)
(Fresenius Kabi, USA, LLC)

NDC Code65219-258-10
Package Description10 POUCH in 1 CASE (65219-258-10) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG (65219-258-01)
Product NDC65219-258
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameCardioplegic Solution
Non-Proprietary NamePotassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride
Dosage FormINJECTION, SOLUTION
UsageINTRA-ARTERIAL
Start Marketing Date20220606
Marketing Category NameANDA
Application NumberANDA214623
ManufacturerFresenius Kabi, USA, LLC
Substance NameCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Strength17.6; 325.3; 119.3; 643
Strength Unitmg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacy 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]

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