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Drug Product Composition: NITROFURANTOIN MACROCRYSTALLINE

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

USFDA APPLICATION NUMBER - 16620 / DOSAGE - CAPSULE;ORAL - 100MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROFURANTOIN(UNII: 927AH8112L)
(NITROFURANTOIN - UNII:927AH8112L)
NITROFURANTOIN50mg

Inactive Ingredients

Ingredient Name
REMEDYREPACK INC.
American Health Packaging
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Liberty Pharmaceuticals, Inc.
NuCare Pharmaceuticals,Inc.
NCS HealthCare of KY, Inc dba Vangard Labs
Lake Erie Medical DBA Quality Care Products LLC
PD-Rx Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
Unit Dose Services
A-S Medication Solutions
A-S Medication Solutions LLC
BluePoint Laboratories
Bryant Ranch Prepack
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Mylan Institutional Inc.
Mylan Pharmaceuticals Inc.
NuCare Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
REMEDYREPACK INC.
NuCare Pharmaceuticals Industries, Inc.
ALGINIC ACID(8C3Z4148WZ)                    
ALUMINUM OXIDE(LMI26O6933)                
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                    
ANHYDROUS LACTOSE(3SY5LH9PMK)                    
BUTYL ALCOHOL(8PJ61P6TS3)                    
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                    
D&C RED NO. 33(9DBA0SBB0L)            
D&C YELLOW NO. 10(35SW5USQ3G)  
DIPROPYLENE GLYCOL(E107L85C40)                    
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)      
GELATIN(2G86QN327L)       
GELATIN, UNSPECIFIED(2G86QN327L)           
HYDRATED SILICA(Y6O7T4G8P9)                    
HYPROMELLOSES(3NXW29V3WO)                    
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)             
LACTOSE MONOHYDRATE(EWQ57Q8I5X)      
LACTOSE(J2B2A4N98G)                 
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)                
MAGNESIUM STEARATE(70097M6I30)               
POTASSIUM HYDROXIDE(WZH3C48M4T)                   
PROPYLENE GLYCOL(6DC9Q167V3)       
SHELLAC(46N107B71O)       
SILICON DIOXIDE(ETJ7Z6XBU4)               
SODIUM LAURYL SULFATE(368GB5141J)            
STARCH, CORN(O8232NY3SJ) 
TALC(7SEV7J4R1U)  
TITANIUM DIOXIDE(15FIX9V2JP)