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Drug Product Composition: NITROFURANTOIN MACROCRYSTALLINE

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$ API Ref.Price (USD/KG) : 337Xls

USFDA APPLICATION NUMBER - 20064 / DOSAGE - CAPSULE;ORAL - 75MG;25MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN MONOHYDRATE(UNII: E1QI2CQQ1I)
(NITROFURANTOIN - UNII:927AH8112L)
NITROFURANTOIN75mg
NITROFURANTOIN(UNII: 927AH8112L)
(NITROFURANTOIN - UNII:927AH8112L)
NITROFURANTOIN25mg

Inactive Ingredients

Ingredient Name
AvKARE, Inc.
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Preferred Pharmaceuticals Inc.
REMEDYREPACK INC.
St. Mary's Medical Park Pharmacy
Avera McKennan Hospital
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
NuCare Pharmaceuticals, Inc.
REMEDYREPACK INC.
Actavis Pharma, Inc.
A-S Medication Solutions
American Health Packaging
BluePoint Laboratories
Bryant Ranch Prepack
Preferred Pharmaceuticals, Inc.
ALCOHOL(3K9958V90M)           
ALGINIC ACID(8C3Z4148WZ)            
AMMONIA(5138Q19F1X)           
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)              
BUTYL ALCOHOL(8PJ61P6TS3)           
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)              
CARBOMER 934(Z135WT9208)             
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(F68VH75CJC)               
CARBOMER HOMOPOLYMER TYPE A(F68VH75CJC)              
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)(K6MOM3T5YL)            
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(Z135WT9208)          
CARBOXYMETHYLCELLULOSE(05JZI7B19X)            
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)              
D&C RED NO. 28(767IP0Y5NH)             
D&C YELLOW NO. 10(35SW5USQ3G)   
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)          
FERRIC OXIDE RED(1K09F3G675)            
FERRIC OXIDE YELLOW(EX438O2MRT)         
FERROSOFERRIC OXIDE(XM0M87F357)       
GELATIN(2G86QN327L)        
GELATIN, UNSPECIFIED(2G86QN327L)        
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)              
HYPROMELLOSES(3NXW29V3WO)              
ISOPROPYL ALCOHOL(ND2M416302)           
LACTOSE MONOHYDRATE(EWQ57Q8I5X)        
LACTOSE(J2B2A4N98G)          
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)            
MAGNESIUM STEARATE(70097M6I30) 
MALTODEXTRIN(7CVR7L4A2D)            
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)              
POTASSIUM HYDROXIDE(WZH3C48M4T)           
POVIDONE(FZ989GH94E)         
POVIDONE, UNSPECIFIED(FZ989GH94E)          
POVIDONES(FZ989GH94E)              
PROPYLENE GLYCOL(6DC9Q167V3)        
SHELLAC(46N107B71O)        
SILICON DIOXIDE(ETJ7Z6XBU4)          
SODIUM ALGINATE(C269C4G2ZQ)            
SODIUM HYDROXIDE(55X04QC32I)            
SODIUM LAURYL SULFATE(368GB5141J)         
STARCH, CORN(O8232NY3SJ)   
SUCROSE(C151H8M554)          
TALC(7SEV7J4R1U)   
TITANIUM DIOXIDE(15FIX9V2JP) 
WATER(059QF0KO0R)