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Drug Product Composition: Potassium Chloride API

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USFDA APPLICATION NUMBER - 19123 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MEQ

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Potassium Chloride(UNII: 660YQ98I10)
(Potassium Cation - UNII:295O53K152)
Potassium Chloride750mg | 600mg

Inactive Ingredients

Ingredient Name
Aphena Pharma Solutions - Tennessee, LLC
Cardinal Health
Legacy Pharmaceutical Packaging
Liberty Pharmaceuticals, Inc.
REMEDYREPACK INC.
Upsher-Smith Laboratories, Inc.
Vensun Pharmaceuticals, Inc.
Mckesson Rxpak Inc
NCS HealthCare of KY, Inc dba Vangard Labs
REMEDYREPACK INC.
Sandoz Inc.
Bryant Ranch Prepack
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Lake Erie Medical DBA Quality Care Products LLC
Mylan Institutional Inc.
A-S Medication Solutions
A-S Medication Solutions LLC
American Health Packaging
PD-Rx Pharmaceuticals, Inc.
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
St Marys Medical Park Pharmacy
aluminum oxide(LMI26O6933)               
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)                    
Carnauba Wax(R12CBM0EIZ)                    
D&C yellow no. 10(35SW5USQ3G)           
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)                  
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)                  
ETHYLCELLULOSES(7Z8S9VYZ4B)                  
FD&C blue no. 1(H3R47K3TBD)         
FD&C blue no. 2(L06K8R7DQK)             
FD&C YELLOW NO. 5(I753WB2F1M)                  
FD&C YELLOW NO. 6(H77VEI93A8)         
FERRIC OXIDE RED(1K09F3G675)                  
FERRIC OXIDE YELLOW(EX438O2MRT)                  
hydrogenated cottonseed oil(Z82Y2C65EA)     
MAGNESIUM STEARATE(70097M6I30)  
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                   
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)          
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)          
polyvinyl alcohol(532B59J990)         
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)          
silicon dioxide(ETJ7Z6XBU4)     
STEARIC ACID(4ELV7Z65AP)                  
talc(7SEV7J4R1U)  
titanium dioxide(15FIX9V2JP)