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Drug Product Composition: Valproate

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

USFDA APPLICATION NUMBER - 19680 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIVALPROEX SODIUM(UNII: 644VL95AO6)
(VALPROIC ACID - UNII:614OI1Z5WI)
VALPROIC ACID125mg

Inactive Ingredients

Ingredient Name
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
American Health Packaging
Cardinal Health
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
Sandoz Inc.
AMMONIA(5138Q19F1X)     
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)      
COPOVIDONE K25-31(D9C330MD8B)      
COPOVIDONE(D9C330MD8B)      
CROSCARMELLOSE SODIUM(M28OL1HH48)     
D&C RED NO. 28(767IP0Y5NH)  
DIBUTYL SEBACATE(4W5IH7FLNY)     
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)     
ETHYLCELLULOSES(7Z8S9VYZ4B)    
FD&C BLUE NO. 1(H3R47K3TBD)  
FD&C BLUE NO. 2(L06K8R7DQK)     
FERRIC OXIDE RED(1K09F3G675)    
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L)   
GELATIN, UNSPECIFIED(2G86QN327L)    
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)      
HYPROMELLOSES(3NXW29V3WO)    
LACTOSE MONOHYDRATE(EWQ57Q8I5X)     
MAGNESIUM STEARATE(70097M6I30)  
MALTODEXTRIN(7CVR7L4A2D)     
MANNITOL(3OWL53L36A)     
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)     
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)      
OLEIC ACID(2UMI9U37CP)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)      
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)      
POLYSORBATE 80(6OZP39ZG8H)     
POTASSIUM HYDROXIDE(WZH3C48M4T)      
PROPYLENE GLYCOL(6DC9Q167V3)     
RAW SUGAR(8M707QY5GH)      
SHELLAC(46N107B71O)     
SILICON DIOXIDE(ETJ7Z6XBU4)  
SODIUM HYDROXIDE(55X04QC32I)     
SODIUM LAURYL SULFATE(368GB5141J)     
STARCH, CORN(O8232NY3SJ)     
SUCROSE(C151H8M554)     
TALC(7SEV7J4R1U)    
TITANIUM DIOXIDE(15FIX9V2JP) 
TRIACETIN(XHX3C3X673)     
TRIETHYL CITRATE(8Z96QXD6UM)