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Drug Product Composition: duraspiron

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$ API Ref.Price (USD/KG) : 295Xls

USFDA APPLICATION NUMBER - 12151 / DOSAGE - TABLET;ORAL - 100MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
spironolactone(UNII: 27O7W4T232)
(spironolactone - UNII:27O7W4T232)
spironolactone50mg

Inactive Ingredients

Ingredient Name
McKesson Corporation dba SKY Packaging
NuCare Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
Preferred Pharmaceuticals, Inc.
REMEDYREPACK INC.
St Marys Medical Park Pharmacy
Unit Dose Services
Aphena Pharma Solutions - Tennessee, LLC
Avera McKennan Hospital
Bryant Ranch Prepack
Cardinal Health 107, LLC
Greenstone LLC
Major Pharmaceuticals
McKesson Contract Packaging
NCS HealthCare of KY, Inc dba Vangard Labs
Northwind Pharmaceuticals, LLC
Pfizer Laboratories Div Pfizer Inc
PharmPak, Inc.
Quality Care Products, LLC
RedPharm Drug, Inc.
Zydus Lifesciences Limited
Zydus Pharmaceuticals (USA) Inc.
A-S Medication Solutions LLC
Actavis Pharma, Inc.
American Health Packaging
AvPAK
Lake Erie Medical DBA Quality Care Products LLC
NuCare Pharmaceuticals,Inc.
Par Pharmaceutical
PD-Rx Pharmaceuticals, Inc.
REMEDYREPACK INC.
A-S Medication Solutions
Preferred Pharmaceuticals, Inc
St. Mary's Medical Park Pharmacy
ANHYDROUS LACTOSE(3SY5LH9PMK)                           
CALCIUM SULFATE DIHYDRATE(4846Q921YM)                
CALCIUM SULFATE(WAT0DDB505)                      
CALCIUM SULFATE, UNSPECIFIED FORM(WAT0DDB505)                          
CARNAUBA WAX(R12CBM0EIZ)                           
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                 
CROSCARMELLOSE SODIUM(M28OL1HH48)                 
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)                              
CROSPOVIDONE(2S7830E561)                               
CROSPOVIDONE(68401960MK)                           
D&C YELLOW NO. 10(35SW5USQ3G)                                 
DEXTROSE(IY9XDZ35W2)                             
DEXTROSE, UNSPECIFIED FORM(IY9XDZ35W2)                                
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                              
DOCUSATE SODIUM(F05Q2T2JA0)                           
FD&C YELLOW NO. 6(H77VEI93A8)                                 
FERRIC OXIDE RED(1K09F3G675)                         
Ferric Oxide Yellow(EX438O2MRT)                          
FERROSOFERRIC OXIDE(XM0M87F357)                           
HYPROMELLOSE 2910 (15000 MPA.S)(288VBX44JC)                               
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                          
HYPROMELLOSES(3NXW29V3WO)           
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                     
MAGNESIUM STEARATE(70097M6I30) 
MALTODEXTRIN(7CVR7L4A2D)                           
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                          
PEPPERMINT OIL(AV092KU4JH)                             
PEPPERMINT(V95R5KMY2B)               
polydextrose(VH2XOU12IE)               
POLYETHYLENE GLYCOL 3000(SA1B764746)                                 
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)                                
POLYETHYLENE GLYCOL 400(B697894SGQ)                            
POLYETHYLENE GLYCOL 6000(30IQX730WE)                          
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)                          
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                              
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                        
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                      
POLYSORBATE 80(6OZP39ZG8H)                         
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)                               
POVIDONE K25(K0KQV10C35)                              
POVIDONE K29/32(390RMW2PEQ)                                 
POVIDONE K30(U725QWY32X)                         
POVIDONE(FZ989GH94E)                      
POVIDONE, UNSPECIFIED(FZ989GH94E)                         
POVIDONES(FZ989GH94E)                         
SILICON DIOXIDE(ETJ7Z6XBU4)           
sodium benzoate(OJ245FE5EU)                           
SODIUM LAURYL SULFATE(368GB5141J)                        
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                   
STARCH, CORN(O8232NY3SJ)    
STEARIC ACID(4ELV7Z65AP)                               
TALC(7SEV7J4R1U)               
TITANIUM DIOXIDE(15FIX9V2JP)  
TRIACETIN(XHX3C3X673)