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Drug Product Composition: Phenytoin Sodium

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$ API Ref.Price (USD/KG) : 31Xls

USFDA APPLICATION NUMBER - 84349 / DOSAGE - CAPSULE;ORAL - 100MG EXTENDED

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYTOIN SODIUM(UNII: 4182431BJH)
(PHENYTOIN - UNII:6158TKW0C5)
PHENYTOIN SODIUM30mg

Inactive Ingredients

Ingredient Name
Unichem Pharmaceuticals (USA), Inc.
A-S Medication Solutions
Cardinal Health
REMEDYREPACK INC.
Upsher-Smith Laboratories, Inc.
Bryant Ranch Prepack
Clinical Solutions Wholesale
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
A-S Medication Solutions LLC
AvPAK
Lake Erie Medical DBA Quality Care Products LLC
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
REMEDYREPACK INC.
KAISER FOUNDATION HOSPITALS
Lupin Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)                  
benzyl alcohol(LKG8494WBH)               
BUTYL ALCOHOL(8PJ61P6TS3)                
butylparaben(3QPI1U3FV8)               
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)               
D&C RED NO. 28(767IP0Y5NH)         
D&C RED NO. 33(9DBA0SBB0L)           
D&C YELLOW NO. 10(35SW5USQ3G)      
EDETATE CALCIUM DISODIUM(25IH6R4SGF)               
FD&C BLUE NO. 1(H3R47K3TBD)         
FD&C BLUE NO. 2(L06K8R7DQK)           
FD&C RED NO. 3(PN2ZH5LOQY)             
FD&C RED NO. 40(WZB9127XOA)          
FD&C YELLOW NO. 6(H77VEI93A8)               
FERROSOFERRIC OXIDE(XM0M87F357)       
GELATIN(2G86QN327L)       
GELATIN, UNSPECIFIED(2G86QN327L)          
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(S38J6RZN16)                  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(S38J6RZN16)             
Hydroxypropyl Cellulose (type H)(RFW2ET671P)                  
hydroxypropyl cellulose(RFW2ET671P)                  
HYPROMELLOSE 2910 (4000 MPA.S)(RN3152OP35)                
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)               
HYPROMELLOSES(3NXW29V3WO)                 
LACTITOL MONOHYDRATE(UH2K6W1Y64)               
LACTOSE MONOHYDRATE(EWQ57Q8I5X)           
MAGNESIUM OXIDE(3A3U0GI71G)        
Magnesium Stearate(70097M6I30) 
Mannitol(3OWL53L36A)                 
methylparaben(A2I8C7HI9T)               
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)             
POTASSIUM HYDROXIDE(WZH3C48M4T)              
POVIDONE(FZ989GH94E)                 
POVIDONE, UNSPECIFIED(FZ989GH94E)                
POVIDONES(FZ989GH94E)                 
PROPYLENE GLYCOL(6DC9Q167V3)        
propylparaben(Z8IX2SC1OH)               
SHELLAC(46N107B71O)       
SILICON DIOXIDE(ETJ7Z6XBU4)          
sodium lauryl sulfate(368GB5141J)     
SODIUM PROPIONATE(DK6Y9P42IN)               
STARCH, CORN(O8232NY3SJ)                  
SUCROSE STEARATE(274KW0O50M)                  
SUCROSE(C151H8M554)        
TALC(7SEV7J4R1U)      
TITANIUM DIOXIDE(15FIX9V2JP)