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Drug Product Composition: Mycophenolate Sodium

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$ API Ref.Price (USD/KG) : 232Xls

USFDA APPLICATION NUMBER - 50791 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 360MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOPHENOLATE SODIUM(UNII: WX877SQI1G)
(MYCOPHENOLIC ACID - UNII:HU9DX48N0T)
MYCOPHENOLIC ACID180mg

Inactive Ingredients

Ingredient Name
Teva Pharmaceuticals USA, Inc.
Avera McKennan Hospital
Biocon Pharma Inc.
PD-Rx Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc.
Accord Healthcare Inc.
Advagen Pharma Limited
CONCORD BIOTECH LIMITED
Lupin Pharmaceuticals, Inc.
Slate Run Pharmaceuticals, LLC
ALUMINUM OXIDE(LMI26O6933)         
Anhydrous Lactose(3SY5LH9PMK)     
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
CROSCARMELLOSE SODIUM(M28OL1HH48)      
CROSPOVIDONE (12 MPA.S AT 5%)(40UAA97IT9)         
Crospovidone (35 .Mu.M)(40UAA97IT9)         
CROSPOVIDONE(2S7830E561)       
CROSPOVIDONE(68401960MK)         
D&C YELLOW NO. 10(35SW5USQ3G)         
FD&C BLUE NO. 1--ALUMINUM LAKE(J9EQA3S2JM)         
FD&C BLUE NO. 2(L06K8R7DQK)    
Fd&C Blue No. 2--Aluminum Lake(4AQJ3LG584)         
FD&C YELLOW NO. 6(H77VEI93A8)       
Ferric Oxide Red(1K09F3G675)    
FERRIC OXIDE YELLOW(EX438O2MRT)  
FERROSOFERRIC OXIDE(XM0M87F357)      
GLYCERYL MONO AND DICAPRYLOCAPRATE(U72Q2I8C85)         
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)        
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)        
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)        
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)      
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6)         
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)         
HYPROMELLOSES(3NXW29V3WO)        
LACTOSE MONOHYDRATE(EWQ57Q8I5X)       
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)         
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)       
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)       
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)         
POLYETHYLENE GLYCOL 400(B697894SGQ)         
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)       
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)(23ZQ42JZZH)         
POLYVINYL ALCOHOL(532B59J990)         
POVIDONE K25(K0KQV10C35)         
POVIDONE K30(U725QWY32X)  
POVIDONE(FZ989GH94E)         
POVIDONE, UNSPECIFIED(FZ989GH94E)         
PROPYLENE GLYCOL(6DC9Q167V3)       
SHELLAC(46N107B71O)         
Silicon Dioxide(ETJ7Z6XBU4)  
SODIUM BICARBONATE(8MDF5V39QO)      
SODIUM LAURYL SULFATE(368GB5141J)      
STARCH, CORN(O8232NY3SJ)    
TALC(7SEV7J4R1U)  
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)        
TRIETHYL CITRATE(8Z96QXD6UM)