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Drug Product Composition: Promethazine Hydrochloride

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$ API Ref.Price (USD/KG) : 62Xls

USFDA APPLICATION NUMBER - 88763 / DOSAGE - SYRUP;ORAL - 10MG/5ML;6.25MG/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
CODEINE PHOSPHATE10mg in 5
PROMETHAZINE HYDROCHLORIDE(UNII: R61ZEH7I1I)
(PROMETHAZINE - UNII:FF28EJQ494)
PROMETHAZINE HYDROCHLORIDE6.25mg in 5

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Amneal Pharmaceuticals LLC
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lohxa
NuCare Pharmaceuticals,Inc.
Par Pharmaceutical
Pharmaceutical Associates, Inc.
Preferred Pharmaceuticals, Inc
Preferred Pharmaceuticals, Inc.
Proficient Rx LP
RPK Pharmaceuticals, Inc.
Sun Pharmaceutical Industries, Inc.
Actavis Mid Atlantic LLC
Bryant Ranch Prepack
ALCOHOL(3K9958V90M)  
ANHYDROUS CITRIC ACID(XF417D3PSL)       
ASCORBIC ACID(PQ6CK8PD0R)   
CITRIC ACID MONOHYDRATE(2968PHW8QP)      
CORN SYRUP(9G5L16BK6N)            
D&C RED NO. 33(9DBA0SBB0L)         
D&C YELLOW NO. 10(35SW5USQ3G)          
EDETATE DISODIUM(7FLD91C86K)        
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C RED NO. 3(PN2ZH5LOQY)        
FD&C RED NO. 40(WZB9127XOA)         
GLYCERIN(PDC6A3C0OX)       
MENTHOL(L7T10EIP3A)          
MENTHOL, UNSPECIFIED FORM(L7T10EIP3A)            
METHYLPARABEN(A2I8C7HI9T) 
PROPYLENE GLYCOL(6DC9Q167V3)      
PROPYLPARABEN(Z8IX2SC1OH)      
SACCHARIN SODIUM DIHYDRATE(SB8ZUX40TY)            
SACCHARIN SODIUM(SB8ZUX40TY)      
SACCHARIN(FST467XS7D)             
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)    
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)          
SODIUM PROPIONATE ANHYDROUS(391O0PO49R)             
SORBITOL(506T60A25R)             
SUCRALOSE(96K6UQ3ZD4)          
SUCROSE(C151H8M554)   
TRISODIUM CITRATE DIHYDRATE(B22547B95K)             
WATER(059QF0KO0R)