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Drug Product Composition: Valproate

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$ API Ref.Price (USD/KG) : 37Xls

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)