FDA.reportPublic FDA data

Application 018876

Type
NDA
Sponsor
ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;74.5MG/100ML;300MG/100MLNoNo
002POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100ML;300MG/100MLNoNo
003POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;224MG/100ML;300MG/100MLNoNo
004POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;298MG/100ML;300MG/100MLNoNo
005POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;74.5MG/100ML;300MG/100MLNoNo
006POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100ML;300MG/100MLNoNo
007POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;224MG/100ML;300MG/100MLNoNo
008POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;298MG/100ML;300MG/100MLNoNo
009POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;149MG/100ML;300MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7998Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDEHospira, Inc.NDACurrent