Application Nr Approved Date Route Status External Links
NDA019635 2016-08-11 Intravenous RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage These Intravenous Solutions Are Indicated For Use In Adults And Pediatric Patients As Sources Of Electrolytes And Water For Hydration. 0.9% Sodium Chloride Injection Usp Is Indicated For Extracellular Fluid Replacement, Treatment Of Metabolic Alkalosis In The Presence Of Fluid Loss And Mild Sodium Depletion. 0.9% Sodium Chloride Injection Usp Is Also Indicated For Use As A Priming Solution In Hemodialysis Procedures And May Be Used To Initiate And Terminate Blood Transfusions Without Hemolyzing Red Blood Cells. 0.45% Sodium Chloride Injection Usp Is Primarily A Hydrating Solution And May Be Used To Assess The Status Of The Kidneys, Since More Water Is Provided Than Is Required For Excretion Of Salt. It May Also Be Used In The Treatment Of Hyperosmolar Diabetes Where The Use Of Dextrose Is Inadvisable And There Is A Need For Large Amounts Of Fluid Without An Excess Of Sodium Ions. Sodium Chloride Injections Usp Are Also Indicated As Pharmaceutic Aids And Diluents For The Infusion Of Compatible Drug Additives. Refer To Prescribing Information Accompanying Additive Drugs.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sodium Chloride

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