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Drug Product Composition: Dexamethasone Acetate

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$ API Ref.Price (USD/KG) : 698Xls

USFDA APPLICATION NUMBER - 88316 / DOSAGE - TABLET;ORAL - 6MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE(UNII: 7S5I7G3JQL)
(DEXAMETHASONE - UNII:7S5I7G3JQL)
DEXAMETHASONE6mg

Inactive Ingredients

Ingredient Name
Hikma Pharmaceuticals USA, Inc.
Fera Pharmaceuticals, LLC
Par Pharmaceutical Inc.
Pragma Pharmaceuticals, LLC
Avera McKennan Hospital
ALCOHOL(3K9958V90M)    
anhydrous lactose(3SY5LH9PMK)  
BENZOIC ACID(8SKN0B0MIM)    
CHERRY(BUC5I9595W)    
CITRIC ACID MONOHYDRATE(2968PHW8QP)    
CROSCARMELLOSE SODIUM(M28OL1HH48)  
D&C Yellow No. 10(35SW5USQ3G) 
EDETATE DISODIUM(7FLD91C86K)    
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C GREEN NO. 3(3P3ONR6O1S)   
FD&C RED NO. 3(PN2ZH5LOQY)    
FD&C RED NO. 40(WZB9127XOA)   
FD&C YELLOW NO. 5(I753WB2F1M)  
FD&C YELLOW NO. 6(H77VEI93A8)   
FERRIC OXIDE YELLOW(EX438O2MRT)    
GLYCERIN(PDC6A3C0OX)    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)   
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)    
microcrystalline cellulose(OP1R32D61U)  
PROPYLENE GLYCOL(6DC9Q167V3)    
PROPYLPARABEN(Z8IX2SC1OH)    
SORBITOL(506T60A25R)    
STARCH, CORN(O8232NY3SJ)   
stearic acid(4ELV7Z65AP)  
SUCROSE(C151H8M554)   
WATER(059QF0KO0R)