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Drug Product Composition: Dextromethorphan Hydrobromide

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$ API Ref.Price (USD/KG) : 156Xls

USFDA APPLICATION NUMBER - 18658 / DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 30MG HYDROBROMIDE/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan(UNII: 7355X3ROTS)
(Dextromethorphan - UNII:7355X3ROTS)
Dextromethorphan30mg in 5

Inactive Ingredients

Ingredient Name
Reckitt Benckiser LLC
REMEDYREPACK INC.
Amneal Pharmaceuticals LLC
American Sales Company
Amerisource Bergen
CVS Pharmacy
DZA Brands LLC
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
HyVee Inc
Kmart Corporation
Kroger Company
L. Perrigo Company
Shopko Stores Operating Co., LLC
Strategic Sourcing Services LLC
Supervalu Inc
Topco Associates LLC
Wal-Mart Stores Inc
Cardinal Health
Kinray
Safeway
Reckitt Benckiser, Inc.
anhydrous citric acid(XF417D3PSL)                   
CITRIC ACID MONOHYDRATE(2968PHW8QP)                   
CORN OIL(8470G57WFM)                    
D&C RED NO. 30(2S42T2808B)       
D&C RED NO. 33(9DBA0SBB0L)                  
D&C YELLOW NO. 10(35SW5USQ3G)       
EDETATE DISODIUM(7FLD91C86K)                  
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)                    
ETHYLCELLULOSES(7Z8S9VYZ4B)                   
FD&C BLUE NO. 1(H3R47K3TBD)            
FD&C YELLOW NO. 6(H77VEI93A8)                   
GLYCERIN(PDC6A3C0OX)    
HIGH FRUCTOSE CORN SYRUP(XY6UN3QB6S)  
HYDROCHLORIC ACID(QTT17582CB)                    
METHYLPARABEN(A2I8C7HI9T) 
Polistirex(5H9W9GTW27)        
polyethylene glycol 3350(G2M7P15E5P)                  
POLYSORBATE 80(6OZP39ZG8H) 
POLYVINYL ACETATE(32K497ZK2U)      
POVIDONE(FZ989GH94E)                
POVIDONE, UNSPECIFIED(FZ989GH94E)            
POVIDONES(FZ989GH94E)                 
propylene glycol(6DC9Q167V3)                  
PROPYLPARABEN(Z8IX2SC1OH) 
SODIUM HYDROXIDE(55X04QC32I)                    
SODIUM METABISULFITE(4VON5FNS3C)    
SODIUM POLYSTYRENE SULFONATE(1699G8679Z)   
SUCROSE(C151H8M554) 
TARTARIC ACID(W4888I119H)    
TRAGACANTH(2944357O2O) 
TRIACETIN(XHX3C3X673)    
WATER(059QF0KO0R) 
XANTHAN GUM(TTV12P4NEE)