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Drug Product Composition: Dexamethasone Acetate

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

USFDA APPLICATION NUMBER - 84613 / DOSAGE - TABLET;ORAL - 0.75MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE(UNII: 7S5I7G3JQL)
(DEXAMETHASONE - UNII:7S5I7G3JQL)
DEXAMETHASONE0.75mg | 2mg | 4mg

Inactive Ingredients

Ingredient Name
Hikma Pharmaceuticals USA, Inc.
Fera Pharmaceuticals, LLC
Par Pharmaceutical Inc.
Pragma Pharmaceuticals, LLC
A-S Medication Solutions LLC
PD-Rx Pharmaceuticals, Inc.
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)