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Drug Product Composition: Potassium Chloride

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USFDA APPLICATION NUMBER - 19123 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MEQ

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
BluePoint Laboratories
Bryant Ranch Prepack
DOH CENTRAL PHARMACY
NCS HealthCare of KY, Inc dba Vangard Labs
REMEDYREPACK INC.
Cardinal Health 107, LLC
Aphena Pharma Solutions - Tennessee, LLC
Cardinal Health
Legacy Pharmaceutical Packaging
Liberty Pharmaceuticals, Inc.
Upsher-Smith Laboratories, Inc.
Vensun Pharmaceuticals, Inc.
Apace Packaging LLC
Aphena Pharma Solutions - Tennessee, Inc.
AvKARE, Inc.
Clinical Solutions Wholesale
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Eurand, Inc.
Lake Erie Medical DBA Quality Care Products LLC
McKesson Contract Packaging
McKesson Packaging Services Business Unit of McKesson Corporation
NuCare Pharmaceuticals, Inc.
Safecor Health, LLC
St Marys Medical Park Pharmacy .
Unit Dose Services
PD-Rx Pharmaceuticals, Inc.
Sandoz Inc
Sandoz Inc.
Preferred Pharmaceuticals Inc.
Mckesson Rxpak Inc
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Mylan Institutional Inc.
A-S Medication Solutions
A-S Medication Solutions LLC
American Health Packaging
REMEDYREPACK INC.
St Marys Medical Park Pharmacy
ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ)                                
ALCOHOL(3K9958V90M)                                   
ALUMINUM OXIDE(LMI26O6933)                               
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)                                    
Carnauba Wax(R12CBM0EIZ)                                    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                  
CETYL ALCOHOL(936JST6JCN)                                    
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)                                    
Croscarmellose Sodium(M28OL1HH48)                    
CROSPOVIDONE (120 .MU.M)(68401960MK)                                    
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                                 
CROSPOVIDONE(2S7830E561)                                 
CROSPOVIDONE(68401960MK)                              
CROSPOVIDONE, UNSPECIFIED(2S7830E561)                                   
D&C YELLOW NO. 10(35SW5USQ3G)                          
DIETHYL PHTHALATE(UF064M00AF)                        
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)                                
ETHYLCELLULOSE (100 CPS)(47MLB0F1MV)                                    
ETHYLCELLULOSE (100 MPA.S)(47MLB0F1MV)                         
ETHYLCELLULOSE (20 MPA.S)(BJG0S321QY)                         
ETHYLCELLULOSE (45 MPA.S)(V7AD894FAZ)                                   
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)                               
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)                     
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                                    
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                                    
ISOPROPYL ALCOHOL(ND2M416302)                                   
magnesium stearate(70097M6I30)                  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                        
PARAFFIN(I9O0E3H2ZE)                                    
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                                   
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                          
polyethylene glycols(3WJQ0SDW1A)                          
POLYVINYL ACETATE(32K497ZK2U)                                    
POLYVINYL ALCOHOL(532B59J990)                         
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                          
POVIDONE K30(U725QWY32X)                                    
silicon dioxide(ETJ7Z6XBU4)             
Sodium Lauryl Sulfate(368GB5141J)                                  
STEARIC ACID(4ELV7Z65AP)                                  
talc(7SEV7J4R1U)                  
TITANIUM DIOXIDE(15FIX9V2JP)                  
Triethyl Citrate(8Z96QXD6UM)