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    Drug Product Composition: Valproate

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    Valproate

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    USFDA APPLICATION NUMBER - 21168 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIVALPROEX SODIUM(UNII: 644VL95AO6)
    (VALPROIC ACID - UNII:614OI1Z5WI)     		VALPROIC ACID500mg

    Inactive Ingredients

    Ingredient Name
    Cardinal Health
    McKesson Contract Packaging
    NCS HealthCare of KY, Inc dba Vangard Labs
    Preferred Pharmaceuticals Inc.
    REMEDYREPACK INC.
    Impax Generics
    ATLANTIC BIOLOGICALS CORP.
    AvPAK
    Direct_Rx
    Lupin Pharmaceuticals, Inc.
    Major Pharmaceuticals
    PD-Rx Pharmaceuticals, Inc.
    Safecor Health, LLC
    Wockhardt USA LLC.
    Zydus Pharmaceuticals USA Inc
    A-S Medication Solutions
    Bryant Ranch Prepack
    Preferred Pharmaceuticals, Inc.
    REMEDYREPACK INC.
    Avera McKennan Hospital
    Par Pharmaceutical, Inc.
    Cardinal Health 107, LLC
    BluePoint Laboratories
    AMMONIA(5138Q19F1X)                  
    AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)                      
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                      
    BUTYL ALCOHOL(8PJ61P6TS3)                      
    CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
    COPOVIDONE K25-31(D9C330MD8B)                      
    COPOVIDONE(D9C330MD8B)                      
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                      
    DIBUTYL SEBACATE(4W5IH7FLNY)                   
    ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(P2OM2Q86BI)                
    ETHYL ACRYLATE(71E6178C9T)                      
    ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)                      
    ETHYLCELLULOSE (7 MPA.S)(H3UP11403C)                
    ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)                   
    ETHYLCELLULOSES(7Z8S9VYZ4B)               
    FD&C BLUE NO. 1(H3R47K3TBD)                     
    FD&C BLUE NO. 2(L06K8R7DQK)                      
    FERRIC OXIDE RED(1K09F3G675)               
    FERRIC OXIDE YELLOW(EX438O2MRT)             
    FERROSOFERRIC OXIDE(XM0M87F357)      
    GLYCERYL DIBEHENATE(R8WTH25YS2)                    
    HYDROGENATED COTTONSEED OIL(Z82Y2C65EA)                     
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(R33S7TK2EP)                      
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(S38J6RZN16)                    
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(S38J6RZN16)                      
    HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)(ZYD53NBL45)                     
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(ZYD53NBL45)                  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                  
    HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)                      
    HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI)                
    Hypromellose 2208 (15000 Mpa.S)(Z78RG6M2N2)                    
    HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)                      
    HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)                     
    HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)               
    HYPROMELLOSES(3NXW29V3WO)            
    ISOPROPYL ALCOHOL(ND2M416302)                      
    LACTOSE MONOHYDRATE(EWQ57Q8I5X)           
    LACTOSE(J2B2A4N98G)                     
    LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)                     
    LECITHIN, SOYBEAN(1DI56QDM62)                  
    MAGNESIUM STEARATE(70097M6I30)          
    MANNITOL(3OWL53L36A)                      
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)                      
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)                      
    MICROCRYSTALLINE CELLULOSE(OP1R32D61U)               
    OLEIC ACID(2UMI9U37CP)                   
    POLYDEXTROSE(VH2XOU12IE)                  
    POLYETHYLENE GLYCOL 1000000(HZ58M6D839)                      
    POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                
    POLYETHYLENE GLYCOL 400(B697894SGQ)                     
    POLYETHYLENE GLYCOL 6000(30IQX730WE)                     
    POLYETHYLENE GLYCOL 8000(Q662QK8M3B)                      
    POLYETHYLENE GLYCOL(3WJQ0SDW1A)                     
    POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)             
    POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                 
    POLYVINYL ALCOHOL(532B59J990)                     
    POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)          
    POTASSIUM SORBATE(1VPU26JZZ4)                   
    POVIDONE K12(333AG72FWJ)                      
    POVIDONE(FZ989GH94E)                    
    POVIDONE, UNSPECIFIED(FZ989GH94E)                      
    POVIDONES(FZ989GH94E)                     
    PROPYLENE GLYCOL(6DC9Q167V3)            
    SHELLAC(46N107B71O)              
    silicon dioxide (ETJ7Z6XBU4)                      
    SILICON DIOXIDE(ETJ7Z6XBU4)  
    STARCH, CORN(O8232NY3SJ)                      
    STEARIC ACID(4ELV7Z65AP)                     
    TALC(7SEV7J4R1U)      
    TITANIUM DIOXIDE(15FIX9V2JP) 
    TRIACETIN(XHX3C3X673)                  
    XANTHAN GUM(TTV12P4NEE)