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Drug Product Composition: Sodium Bicarbonate

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$ API Ref.Price (USD/KG) : 164Xls

USFDA APPLICATION NUMBER - 22281 / DOSAGE - CAPSULE;ORAL - 20MG;1.1GM

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE(UNII: KG60484QX9)
(OMEPRAZOLE - UNII:KG60484QX9)
OMEPRAZOLE20mg
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
(BICARBONATE ION - UNII:HN1ZRA3Q20)
SODIUM BICARBONATE1100mg

Inactive Ingredients

Ingredient Name
Akron Pharma Inc
AvKARE, Inc.
Cipla USA Inc.
Medarbor Llc
Par Pharmaceutical Inc.
Dr.Reddy's Laboratories Limited
Bayer HealthCare LLC
Guardian Drug Company
Northstar Rx LLC
Oceanside Pharmaceuticals
Prasco Laboratories
HyVee Inc
Topco Associates LLC
ALCOHOL(3K9958V90M)        
AMMONIA(5138Q19F1X)         
BUTYL ALCOHOL(8PJ61P6TS3)          
CROSCARMELLOSE SODIUM(M28OL1HH48)  
D&C YELLOW NO. 10(35SW5USQ3G)            
FD&C BLUE NO. 1(H3R47K3TBD)     
FD&C BLUE NO. 2(L06K8R7DQK)          
FD&C RED NO. 3(PN2ZH5LOQY)          
FD&C RED NO. 40(WZB9127XOA)        
FERROSOFERRIC OXIDE(XM0M87F357)         
GELATIN(2G86QN327L)      
GELATIN, UNSPECIFIED(2G86QN327L)           
ISOPROPYL ALCOHOL(ND2M416302)         
MAGNESIUM STEARATE(70097M6I30)          
POLYSORBATE 80(6OZP39ZG8H)          
POTASSIUM HYDROXIDE(WZH3C48M4T)       
PROPYLENE GLYCOL(6DC9Q167V3)     
SHELLAC(46N107B71O)      
SHELLAC(MB5IUD6JUA)            
silicon dioxide(ETJ7Z6XBU4)            
SODIUM LAURYL SULFATE(368GB5141J)      
SODIUM STEARYL FUMARATE(7CV7WJK4UI)   
SODIUM(9NEZ333N27)            
titanium dioxide(15FIX9V2JP)