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Drug Product Composition: 04273_RIEDEL

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USFDA APPLICATION NUMBER - 207026 / DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcium Chloride(UNII: M4I0D6VV5M)
(Chloride Ion - UNII:Q32ZN48698)
Calcium Chloride0.139g in 1
Magnesium Chloride(UNII: 02F3473H9O)
(Chloride Ion - UNII:Q32ZN48698)
Magnesium Chloride0.071g in 1 | 0.071g in 1
Potassium Chloride(UNII: 660YQ98I10)
(Chloride Ion - UNII:Q32ZN48698)
Potassium Chloride0.298g in 1 | 0.298g in 1
Sodium Bicarbonate(UNII: 8MDF5V39QO)
(Bicarbonate Ion - UNII:HN1ZRA3Q20)
Sodium Bicarbonate2.1g in 1 | 2.936g in 1
Sodium Chloride(UNII: 451W47IQ8X)
(Chloride Ion - UNII:Q32ZN48698)
Sodium Chloride6.603g in 1 | 6.023g in 1
Sodium Phosphate, Dibasic(UNII: GR686LBA74)
(Phosphate Ion - UNII:NK08V8K8HR)
Sodium Phosphate, Dibasic0.146g in 1 | 0.146g in 1

Inactive Ingredients

Ingredient Name
Gambro Renal Products
Carbon Dioxide(142M471B3J)
Hydrochloric Acid(QTT17582CB)
Water(059QF0KO0R)