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Drug Product Composition: Depakine

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

USFDA APPLICATION NUMBER - 18723 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM(UNII: 644VL95AO6)
(VALPROIC ACID - UNII:614OI1Z5WI)
VALPROIC ACID250mg

Inactive Ingredients

Ingredient Name
NCS HealthCare of KY, Inc dba Vangard Labs
A-S Medication Solutions
BluePoint Laboratories
Medsource Pharmaceuticals
REMEDYREPACK INC.
Avera McKennan Hospital
Lake Erie Medical DBA Quality Care Products LLC
Cardinal Health
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Lupin Pharmaceuticals, Inc.
McKesson Packaging Services a business unit of McKesson Corporation
Mylan Institutional Inc.
Mylan Pharmaceutical Inc.
Wockhardt USA LLC.
Teva Pharmaceuticals USA, Inc.
Qualitest Pharmaceuticals
Clinical Solutions Wholesale
Unit Dose Services
McKesson Contract Packaging
REMEDYREPACK INC.
Upsher-Smith Laboratories, Inc.
Bryant Ranch Prepack
2-(3-OXAZOLIDINYL)ETHYL METHACRYLATE(K3L37MQ2NJ)                     
ALCOHOL(3K9958V90M)                 
AMMONIA(5138Q19F1X)                  
BUTYL ALCOHOL(8PJ61P6TS3)                
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)         
COPOVIDONE K25-31(D9C330MD8B)                   
CROSCARMELLOSE SODIUM(M28OL1HH48)                 
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                     
CROSPOVIDONE(2S7830E561)                     
CROSPOVIDONE(68401960MK)                     
D&C RED NO. 27(2LRS185U6K)                     
D&C RED NO. 30(2S42T2808B)             
D&C YELLOW NO. 10(35SW5USQ3G)                     
DIACETYLATED MONOGLYCERIDES(5Z17386USF)                     
DIETHYL PHTHALATE(UF064M00AF)                     
DIMETHICONE(92RU3N3Y1O)                     
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)                     
FD&C BLUE NO. 1(H3R47K3TBD)                     
FD&C BLUE NO. 2(L06K8R7DQK)       
FD&C Red No. 40(WZB9127XOA)          
FD&C YELLOW NO. 6(H77VEI93A8)        
Ferric Oxide Red(1K09F3G675)           
FERRIC OXIDE YELLOW(EX438O2MRT)           
FERROSOFERRIC OXIDE(XM0M87F357)        
GLYCERYL BEHENATE/EICOSADIOATE(73CJJ317SR)                     
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)                     
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)                     
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)                     
HYDROXYPROPYL CELLULOSE(RFW2ET671P)                    
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(2165RE0K14)                 
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)                     
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)                    
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)          
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)                     
ISOBUTYL ALCOHOL(56F9Z98TEM)                     
ISOPROPYL ALCOHOL(ND2M416302)                
LACTOSE MONOHYDRATE(EWQ57Q8I5X)            
LECITHIN, SOYBEAN(1DI56QDM62)                    
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(2165RE0K14)                     
MAGNESIUM STEARATE(70097M6I30)              
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)        
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)                     
METHACRYLIC ACID(1CS02G8656)                   
METHYLENE CHLORIDE(588X2YUY0A)                     
MICROCRYSTALLINE CELLULOSE 112(X7XJ6RM9Q2)                     
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                  
PEG-12 LAURATE(SP6SI08H7T)                     
PHENOXYISOPROPANOL(87CZY0NY1A)                     
POLYDEXTROSE(VH2XOU12IE)                   
POLYETHYLENE GLYCOL 3000(SA1B764746)                 
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                   
POLYETHYLENE GLYCOL 400(B697894SGQ)                     
POLYETHYLENE GLYCOL 4000(4R4HFI6D95)                    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                     
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                   
POLYSORBATE 80(6OZP39ZG8H)                  
POLYVINYL ALCOHOL(532B59J990)                 
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                   
POVIDONE K12(333AG72FWJ)                     
POVIDONE K30(U725QWY32X)                 
POVIDONE(FZ989GH94E)              
POVIDONE, UNSPECIFIED(FZ989GH94E)                   
POVIDONES(FZ989GH94E)                   
PROPYLENE GLYCOL(6DC9Q167V3)        
SHELLAC(46N107B71O)          
SILICON DIOXIDE(ETJ7Z6XBU4) 
SODIUM BICARBONATE(8MDF5V39QO)        
SODIUM HYDROXIDE(55X04QC32I)                  
sodium lauryl sulfate(368GB5141J)        
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                     
STARCH, CORN(O8232NY3SJ)    
STARCH, PREGELATINIZED CORN(O8232NY3SJ)                    
TALC(7SEV7J4R1U) 
TITANIUM DIOXIDE(15FIX9V2JP)  
TRIACETIN(XHX3C3X673)        
TRIETHYL CITRATE(8Z96QXD6UM) 
vanillin(CHI530446X)