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Drug Product Composition: Potassium Chloride

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USFDA APPLICATION NUMBER - 21703 / DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcium Chloride(UNII: M4I0D6VV5M)
(Chloride Ion - UNII:Q32ZN48698)
Calcium Chloride0.194g in 1 | 0.139g in 1 | 0.139g in 1
Dextrose monohydrate(UNII: LX22YL083G)
(Anhydrous Dextrose - UNII:5SL0G7R0OK)
Dextrose monohydrate1g in 1 | 1g in 1 | 1g in 1 | 1g in 1 | 1g in 1 | 1g in 1
Lactic Acid(UNII: 33X04XA5AT)
(Lactic Acid - UNII:33X04XA5AT)
Lactic Acid0.270g in 1 | 0.270g in 1 | 0.270g in 1 | 0.270g in 1 | 0.270g in 1 | 0.270g in 1 | 0.270g in 1
Magnesium Chloride(UNII: 02F3473H9O)
(Chloride ion - UNII:Q32ZN48698)
Magnesium Chloride0.057g in 1 | 0.057g in 1 | 0.071g in 1 | 0.048g in 1 | 0.048g in 1 | 0.071g in 1 | 0.071g in 1
Potassium Chloride(UNII: 660YQ98I10)
(Chloride Ion - UNII:Q32ZN48698)
Potassium Chloride0.298g in 1 | 0.149g in 1 | 0.149g in 1 | 0.298g in 1 | 0.298g in 1
Sodium Bicarbonate(UNII: 8MDF5V39QO)
(Bicarbonate Ion - UNII:HN1ZRA3Q20)
Sodium Bicarbonate2.936g in 1 | 2.100g in 1 | 2.936g in 1 | 2.936g in 1 | 2.936g in 1 | 2.936g in 1 | 2.936g in 1
Sodium Chloride(UNII: 451W47IQ8X)
(Chloride Ion - UNII:Q32ZN48698)
Sodium Chloride6.137g in 1 | 6.137g in 1 | 6.717g in 1 | 6.137g in 1 | 6.137g in 1 | 6.137g in 1 | 6.137g in 1

Inactive Ingredients

Ingredient Name
Gambro Renal Products
Carbon Dioxide(142M471B3J)
Water(059QF0KO0R)