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Drug Product Composition: Pseudoephedrine Hydrochloride

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$ API Ref.Price (USD/KG) : 53Xls

USFDA APPLICATION NUMBER - 20786 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE(UNII: E6582LOH6V)
(FEXOFENADINE - UNII:E6582LOH6V)
FEXOFENADINE60mg
PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F)
(PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
PSEUDOEPHEDRINE 60mg

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
bryant ranch prepack
Physicians Total Care, Inc.
sanofi-aventis U.S. LLC
McKESSON Corporation
Target Brands Inc.
CARNAUBA WAX(R12CBM0EIZ)  
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
CROSCARMELLOSE SODIUM(M28OL1HH48)
FERRIC OXIDE RED(1K09F3G675)     
FERRIC OXIDE YELLOW(EX438O2MRT)     
HYDROXYPROPYL CELLULOSE (200000 MW)(5Y0974F5PW)     
HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI)     
hypromellose(3NXW29V3WO)    
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)     
HYPROMELLOSES(3NXW29V3WO)    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)     
MAGNESIUM STEARATE(70097M6I30) 
MANNITOL(3OWL53L36A)     
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)    
POLYETHYLENE GLYCOL 400(B697894SGQ)     
POLYETHYLENE GLYCOL 6000(30IQX730WE)     
polyethylene glycol(3WJQ0SDW1A)   
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)     
POWDERED CELLULOSE(SMD1X3XO9M)     
silicon dioxide(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)   
STARCH, PREGELATINIZED CORN(O8232NY3SJ)     
STEARIC ACID(4ELV7Z65AP) 
TRIETHYL CITRATE(8Z96QXD6UM)