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Drug Product Composition: Dexamethasone Acetate

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

USFDA APPLICATION NUMBER - 84611 / DOSAGE - TABLET;ORAL - 0.5MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE(UNII: 7S5I7G3JQL)
(DEXAMETHASONE - UNII:7S5I7G3JQL)
DEXAMETHASONE0.5mg | 0.75mg | 1mg | 1.5mg | 2mg | 4mg | 6mg | 1mg in 1 | 0.5mg in 5 | 0.5mg | 0.75mg | 1mg | 6mg | 2mg | 4mg | 1.5mg

Inactive Ingredients

Ingredient Name
Hikma Pharmaceuticals USA, Inc.
Fera Pharmaceuticals, LLC
Par Pharmaceutical Inc.
Pragma Pharmaceuticals, LLC
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)