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Drug Product Composition: Propafenone Hydrochloride

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$ API Ref.Price (USD/KG) : 35Xls

USFDA APPLICATION NUMBER - 21416 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 225MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPAFENONE HYDROCHLORIDE(UNII: 33XCH0HOCD)
(PROPAFENONE - UNII:68IQX3T69U)
PROPAFENONE HYDROCHLORIDE425mg | 325mg | 225mg

Inactive Ingredients

Ingredient Name
American Health Packaging
AvKARE, Inc.
Golden State Medical Supply, Inc.
Mylan Pharmaceuticals Inc.
Proficient Rx LP
TWi Pharmaceuticals, Inc.
Wilshire Pharmaceuticals
Golden State Medical Supply
Cadila Healthcare Limited
Zydus Pharmaceuticals (USA) Inc.
Prasco Laboratories
Actavis Pharma, Inc.
Glenmark Pharmaceuticals Inc., USA
ALCOHOL(3K9958V90M)           
Ammonia(5138Q19F1X)        
ANHYDROUS LACTOSE(3SY5LH9PMK)          
BUTYL ALCOHOL(8PJ61P6TS3)          
D&C YELLOW NO. 10(35SW5USQ3G)         
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)           
ETHYLCELLULOSES(7Z8S9VYZ4B)           
FD&C BLUE NO. 1(H3R47K3TBD)        
FD&C BLUE NO. 2(L06K8R7DQK)         
FD&C GREEN NO. 3(3P3ONR6O1S)            
FD&C Red No. 3(PN2ZH5LOQY)          
FD&C RED NO. 40(WZB9127XOA)        
FD&C YELLOW NO. 6(H77VEI93A8)          
FERRIC OXIDE RED(1K09F3G675)        
FERRIC OXIDE YELLOW(EX438O2MRT)            
FERROSOFERRIC OXIDE(XM0M87F357)    
GELATIN(2G86QN327L)        
GELATIN, UNSPECIFIED(2G86QN327L)     
HYPROMELLOSE 2910 (10000 MPA.S)(0HO1H52958)            
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)          
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)           
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)          
HYPROMELLOSES(3NXW29V3WO)            
LACTOSE MONOHYDRATE(EWQ57Q8I5X)            
LECITHIN, SOYBEAN(1DI56QDM62)            
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)            
Potassium Hydroxide(WZH3C48M4T)     
POVIDONE(FZ989GH94E)            
POVIDONE, UNSPECIFIED(FZ989GH94E)           
Propylene Glycol(6DC9Q167V3)    
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)          
SODIUM LAURYL SULFATE(368GB5141J)    
TALC(7SEV7J4R1U)            
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)